Breast CancerEarly Phase 1NCT01445054
111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer
A Early Phase 1 study testing 111Indium CHX-A in people with Breast Cancer and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu. An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Lung Cancer
- What is being tested?
- 111Indium CHX-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2007to 20 Aug 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have histological confirmation of primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.
- Primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, CT or MRI.
- Participant must be 18 years or older.
- Availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing IHC or FISH analysis for HER2/Neu (Erb2)
- Chemistry and CBC parameters: serum creatinine less than or equal to 1.4mg/dl. SGOT and SGPT less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with Gilbert s syndrome; platelet count must be greater than 100,00.
- ECOG Performance score of 0 or 1.
- Ability to provide informed consent.
- Negative serum pregnancy test (within 48 hours of imaging agent injection) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of (111)Indium trastuzumab if participant is of child bearing age.
Who cannot join
- Known allergy to trastuzumab.
- Pregnant or lactating women.
- Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
- Participants with an active second malignancy (excluding treated basal cell skin carcinoma).
- History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
- Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
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- Participants with severe claustrophobia.
- A participant who needs a nuclear medicine scan other than a PET scan as part of their work-up cannot enroll until these scans have been completed.
- Gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 Kg)
- With the exception of AT13387 and PU-H71, and Ad5f35HER2ECTM transduced autologous dendritic cell vaccine participants cannot have received another experimental drug within 14 days prior to or during study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase 0 Trial of (111)Indium CHX-A DTPA Trastuzumab Imaging in Cancer
Background:
- Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu.
- An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell.
- Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin.
Read more
Objectives:
-To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not.
Eligibility:
-Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study.
Design:
- Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status.
- Patients have a physical examination and review of medical records.
- Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin.
- Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin.
- Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.
Read the detailed description
Background:
- Trastuzumab (Herceptin ), targets HER2 (aka: neu, ErbB2, c-erb-B2) on the surface of cancer cells and is used in the treatment of breast cancers that overexpress HER2/Neu (Erb2). It has also been demonstrated that other malignancies express HER2/Neu (Erb2).
- Radiolabeling trastuzumab could allow human biodistribution studies, noninvasive assessment of HER2/Neu (Erb2) expression, identification of HER2/Neu (Erb2) positive metastases, monitoring of treatment response and establishment of dosimetry for future radioimmunotherapy.
- We have developed a chelated form of trastuzumab, CHX-A DTPA-trastuzumab, that can bind a number of radioisotopes including (111)In, (212), (213)Bi, (212)Pb (86), (90)Y and (177)Lu which have alpha, beta and gamma emissions for imaging and therapy.
- We believe that the agent will be safe based on the low dose of trastuzumab (up to a maximum of 200 mcg of protein or less than1% of the typical loading dose of trastuzumab in a 70 Kg human) and the low dose of radioactivity (5mCi).
- Whereas trastuzumab therapy is generally only useful in tumors that highly express HER2/Neu (Erb2), (111)In-CHX-A DTPA trastuzumab (henceforth (111)Indium-trastuzumab ) will image tumors that are not only highly expressing HER2/Neu (Erb2) but also tumors that are poorly expressing HER2/Neu (Erb2) as documented by preclinical data.
Objectives:
-The primary objective is to compare uptake of 111Indium trastuzumab with HER2/Neu (Erb2) status of the tumor as determined by IHC
Eligibility:
- Participants with a history of primary or metastatic cancer (other than melanoma, basal cell carcinoma, sarcoma or lymphoma) with known solid tumor size greater than or equal to 1.5 cm.
- Availability of HER2/Neu (Erb2) expression by immunohistochemistry (IHC) or pathology or biopsy specimen can be provided on which such an analysis can be made.
Design:
- The design of this pilot trial follows the concept of a Phase 0 or Exploratory IND (xIND) study.
- Participants with known malignancy greater than or equal to 1.5cm and known HER2/Neu(ErbB2) tumor status (0, 1+, 2+ or 3+) by IHC or FISH.
- After receiving 5 mCi of (111)Indium-trastuzumab, all participants will undergo gamma camera scans at approximately 24-72 hours after injection. In some subjects, an additional imaging session may be required 24 hours after the first set of images as physiologic bowel clearance is variable and may obscure the lesion of interest on the initial scan.
- We will accrue 20 participants to this study.
- A total of 8 blood samples (4 lab tests and up to 4 for pharmacokinetics) will be obtained from each participant to establish toxicity and the pharmacokinetics of clearance.
- Images will be correlated with IHC status using tumor to background ratios and the optimal scanning strategy with regard to HER2/neu(ErbB2) expression will be determined.
- Participants who undergo a therapy thought to target or effect HER2 will have the option of undergoing repeat imaging following therapy.
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Colon Cancer
- Being tested
- 111Indium CHX-A
- Keywords
- 111 Indium Trastuzumab Imaging, PET, Optimal Scanning Strategy, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
111Indium CHX-ADrug
111Indium CHX-A will be administered intravenously over a 10-15 minute period using an intravenous catheter
| Study group | Role | What they receive |
|---|---|---|
| 1-Arm 1 | Experimental | Subjects with primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma. Receives: Drug: 111Indium CHX-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) status of the tumor as determined by IHC
Correlation between uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) and status of the tumor as determined by IHC
Measured: 5 days after intervention
Secondary outcomes (5)
Safety of 111Indium-trastuzumab.
List of adverse event frequency
Measured: 30 days after intervention
Optimal timing of 111Indium-CHX-A DTPA trastuzumab imaging as a function of HER2/ Neu(ErbB2) status.
Optimal timing of 111Indium-CHX-A DTPA trastuzumab imaging as a function of HER2/ Neu(ErbB2) status.
Measured: completion of study
Biodistribution of the agent in normal organs
Biodistribution of the agent in normal organs
Measured: completion of study
Pharmacokinetic serum clearance of 111Indium-CHXA DTPA trastuzumab
Drug level in blood
Measured: 24 hours after intervention
To evaluate the change in 111Indium-CHX-A DTPA trastuzumab uptake in tumors following treatment with a HER2 targeted therapy
Measured: completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study start1 Mar 2007
- Primary completion20 Aug 2014
- Study completion20 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter L Choyke, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445054
- Sponsor's protocol ID
- 070101
- Other IDs
- 07-C-0101
- Status last verified
- 7 Mar 2019
- First submitted
- 30 Sep 2011
- Last updated
- 11 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
Milenic DE, Garmestani K, Brady ED, Albert PS, Ma D, Abdulla A, Brechbiel MW. Targeting of HER2 antigen for the treatment of disseminated peritoneal disease. Clin Cancer Res. 2004 Dec 1;10(23):7834-41. doi: 10.1158/1078-0432.CCR-04-1226.
PubMed 15585615Pegram MD, Pauletti G, Slamon DJ. HER-2/neu as a predictive marker of response to breast cancer therapy. Breast Cancer Res Treat. 1998;52(1-3):65-77. doi: 10.1023/a:1006111117877.
PubMed 10066073Menard S, Casalini P, Campiglio M, Pupa S, Agresti R, Tagliabue E. HER2 overexpression in various tumor types, focussing on its relationship to the development of invasive breast cancer. Ann Oncol. 2001;12 Suppl 1:S15-9. doi: 10.1093/annonc/12.suppl_1.s15.
PubMed 11521715
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Trial of (111)Indium CHX-A DTPA Trastuzumab Imaging in Cancer
- ClinicalTrials.gov ID
- NCT01445054
- Acronym / sponsor ID
- 070101
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Colon Cancer
- Keywords
- 111 Indium Trastuzumab Imaging, PET, Optimal Scanning Strategy, Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Mar 2007
- Primary completion
- 20 Aug 2014 (actual)
- Study completion
- 20 Aug 2014 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu.
- An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell.
- Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin.
Objectives:
-To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not.
Eligibility:
-Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study.
Design:
- Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status.
- Patients have a physical examination and review of medical records.
- Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin.
- Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin.
- Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.
Detailed description
Background:
- Trastuzumab (Herceptin ), targets HER2 (aka: neu, ErbB2, c-erb-B2) on the surface of cancer cells and is used in the treatment of breast cancers that overexpress HER2/Neu (Erb2). It has also been demonstrated that other malignancies express HER2/Neu (Erb2).
- Radiolabeling trastuzumab could allow human biodistribution studies, noninvasive assessment of HER2/Neu (Erb2) expression, identification of HER2/Neu (Erb2) positive metastases, monitoring of treatment response and establishment of dosimetry for future radioimmunotherapy.
- We have developed a chelated form of trastuzumab, CHX-A DTPA-trastuzumab, that can bind a number of radioisotopes including (111)In, (212), (213)Bi, (212)Pb (86), (90)Y and (177)Lu which have alpha, beta and gamma emissions for imaging and therapy.
- We believe that the agent will be safe based on the low dose of trastuzumab (up to a maximum of 200 mcg of protein or less than1% of the typical loading dose of trastuzumab in a 70 Kg human) and the low dose of radioactivity (5mCi).
- Whereas trastuzumab therapy is generally only useful in tumors that highly express HER2/Neu (Erb2), (111)In-CHX-A DTPA trastuzumab (henceforth (111)Indium-trastuzumab ) will image tumors that are not only highly expressing HER2/Neu (Erb2) but also tumors that are poorly expressing HER2/Neu (Erb2) as documented by preclinical data.
Objectives:
-The primary objective is to compare uptake of 111Indium trastuzumab with HER2/Neu (Erb2) status of the tumor as determined by IHC
Eligibility:
- Participants with a history of primary or metastatic cancer (other than melanoma, basal cell carcinoma, sarcoma or lymphoma) with known solid tumor size greater than or equal to 1.5 cm.
- Availability of HER2/Neu (Erb2) expression by immunohistochemistry (IHC) or pathology or biopsy specimen can be provided on which such an analysis can be made.
Design:
- The design of this pilot trial follows the concept of a Phase 0 or Exploratory IND (xIND) study.
- Participants with known malignancy greater than or equal to 1.5cm and known HER2/Neu(ErbB2) tumor status (0, 1+, 2+ or 3+) by IHC or FISH.
- After receiving 5 mCi of (111)Indium-trastuzumab, all participants will undergo gamma camera scans at approximately 24-72 hours after injection. In some subjects, an additional imaging session may be required 24 hours after the first set of images as physiologic bowel clearance is variable and may obscure the lesion of interest on the initial scan.
- We will accrue 20 participants to this study.
- A total of 8 blood samples (4 lab tests and up to 4 for pharmacokinetics) will be obtained from each participant to establish toxicity and the pharmacokinetics of clearance.
- Images will be correlated with IHC status using tumor to background ratios and the optimal scanning strategy with regard to HER2/neu(ErbB2) expression will be determined.
- Participants who undergo a therapy thought to target or effect HER2 will have the option of undergoing repeat imaging following therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-Arm 1 | Experimental | Drug: 111Indium CHX-ASubjects with primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant must have histological confirmation of primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.
- Primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, CT or MRI.
- Participant must be 18 years or older.
- Availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing IHC or FISH analysis for HER2/Neu (Erb2)
- Chemistry and CBC parameters: serum creatinine less than or equal to 1.4mg/dl. SGOT and SGPT less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with Gilbert s syndrome; platelet count must be greater than 100,00.
Key exclusion criteria (10 listed)
- Known allergy to trastuzumab.
- Pregnant or lactating women.
- Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.
- Participants with an active second malignancy (excluding treated basal cell skin carcinoma).
- History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 111Indium CHX-A111Indium CHX-A will be administered intravenously over a 10-15 minute period using an intravenous catheter | Drug | 1-Arm 1 |
Primary outcome
Compare uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) status of the tumor as determined by IHC
Time frame: 5 days after intervention
Correlation between uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) and status of the tumor as determined by IHC
5 secondary outcomes
Safety of 111Indium-trastuzumab.
Time frame: 30 days after intervention
Optimal timing of 111Indium-CHX-A DTPA trastuzumab imaging as a function of HER2/ Neu(ErbB2) status.
Time frame: completion of study
Biodistribution of the agent in normal organs
Time frame: completion of study
Pharmacokinetic serum clearance of 111Indium-CHXA DTPA trastuzumab
Time frame: 24 hours after intervention
To evaluate the change in 111Indium-CHX-A DTPA trastuzumab uptake in tumors following treatment with a HER2 targeted therapy
Time frame: completion of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Background: PubMed 15585615Milenic DE, Garmestani K, Brady ED, Albert PS, Ma D, Abdulla A, Brechbiel MW. Targeting of HER2 antigen for the treatment of disseminated peritoneal disease. Clin Cancer Res. 2004 Dec 1;10(23):7834-41. doi: 10.1158/1078-0432.CCR-04-1226.
- Background: PubMed 10066073Pegram MD, Pauletti G, Slamon DJ. HER-2/neu as a predictive marker of response to breast cancer therapy. Breast Cancer Res Treat. 1998;52(1-3):65-77. doi: 10.1023/a:1006111117877.
- Background: PubMed 11521715Menard S, Casalini P, Campiglio M, Pupa S, Agresti R, Tagliabue E. HER2 overexpression in various tumor types, focussing on its relationship to the development of invasive breast cancer. Ann Oncol. 2001;12 Suppl 1:S15-9. doi: 10.1093/annonc/12.suppl_1.s15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L Choyke, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 111Indium CHX-A in people with Breast Cancer and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) status of the tumor as determined by IHC (time frame: 5 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445054, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.