Small Cell Lung Cancer (SCLC)Phase 1/2NCT02030184
Phase I/II Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas
A Phase 1/2 study testing Rhenium Re 188-P2045 in people with Small Cell Lung Cancer (SCLC) and Neuroendocrine (NE) Tumors, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
There are two parts to this trial. The first study will evaluate increasing doses of Re188 P2045 in patients with advanced small cell lung cancer that has recurred after initial therapy or in patients with other advanced neuroendocrine cancers that have progressed after therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer (SCLC), Neuroendocrine (NE) Tumors, Large Cell Neuroendocrine (NE) Tumors
- What is being tested?
- Rhenium Re 188-P2045
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2017to Jun 2021
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/=18 years.
- Advanced, metastatic or locally recurrent, incurable neuroendocrine tumors (small cell lung cancer, extrapulmonary small cell lung cancer, large cell neuroendocrine lung carcinoma pulmonary carcinoid, GI carcinoid tumor
- Symptomatic CNS metastases: must have received therapy (surgery, XRT, gamma knife)
- Asymptomatic CNS metastatic disease: discuss with Study Chair.
- Histologically-or cytologically documented disease.
- Considered incurable by any combination of therapy including surgery, radiation, chemotherapy.
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- ECOG Performance status 0-2
- Renal function: creatinine clearance > 40 mg/mlxmin (Cockroft-Gault)
- Adequate organ and marrow function by:
- Absolute neutrophil count (ANC) >/=1,500/mcL.
- Platelets >/= 100,000/mcL.
- Total bilirubin within normal institutional limits (WNL)
- AST (SGOT)/ALT (SPGT) </= 2.5 x upper limit of normal (ULN)
- Women (child-bearing potential) and men must use adequate contraception prior to study entry, for duration of study participation, and 90 days after completion of therapy.
- A female of child-bearing potential is any woman is one who has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Merkel cell carcinoma
- Leptomeningeal disease or carcinomatous meningitis
- Chemotherapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered > 3 weeks earlier.
- If the patient was receiving an oral agent, at least 4 half lives should have elapsed.
- Cannot receive any other investigational agent at the time of registration. At least 3 weeks should have elapsed since administration of an IV investigational agent or 4 half lives for an oral investigational agent.
- At least 28 days should have elapsed since administration of a long acting somatostatin analogue.
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- Patients with known brain metastases are eligible (see criteria above). Leptomeningeal metastases are not eligible.
- Patients who have received external beam radiation to more than 20% of marrow.
- No prior radiation to the kidneys.
- Prior systemic radiotherapy are not eligible (except for prior I131 for thyroid cancer more than 1 year earlier).
- Receiving long term immunosuppressive medications for rheumatologic or other disease (e.g. low dose methotrexate, mecaptopurine etc).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to octreotide or other somatostatin analogues.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing (due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Marlene & Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201
About this study
Official title: Phase I/II Dose Escalation Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas as a Single Agent and in Combination With Topotecan
There are two parts to this trial. The first study will evaluate increasing doses of Re188 P2045 in patients with advanced small cell lung cancer that has recurred after initial therapy or in patients with other advanced neuroendocrine cancers that have progressed after therapy.
Re188 P2045 is designed to attach to type 2 somatostatin receptors that are frequently expressed in those cancers and then the radioactivity from Re188 will kill the cancer cell. Only patients who have cancers that can be seen when Tc99 P2045 is administered (also seeks out the SSTR2, but Tc99 images, but does not treat the cells) will be treated.
Read more
Therefore, this approach maximizes the possibility that patients will benefit from treatment in that only those who have cancers that have the target will undergo treatment. The primary purpose of this study will be to determine the highest dose of Re188 P2045 that can be safely administered.
The second study will open after the conclusion of the first. Patients will first undergo the scan with Tc99 P2045 and then be treated with topotecan for three days. Topotecan is a standard chemotherapy drug that is approved for second line therapy for small cell and frequently used for other neuroendocrine cancers. Following that, patients will then be re-evaluated with the Tc99 P2045 scan and if it demonstrates that the tumor is positive for SSTR2, then patients will receive Re188 P2045. The goal of this study is to determine the highest dose of Re188 P2045 that can be safely administered after topotecan as well as to determine if topotecan will increase the chance that the tumor will express SSTR2.
Read the detailed description
This trial will be conducted patients with small cell lung cancer and other neuroendocrine cancers. These include extrapulmonary small cell, gastrointestinal carcinoid tumors that arise from pulmonary lesions, and large cell neuroendocrine (NE) tumors.
First, the dose-limiting toxicity (DLT) and maximally tolerated dose (MTD) for Rhenium Re188-P2045 alone will be determined when it is administered as a single dose, at 80, 90, 130, 170, 210 or (up to) 250 mCi/m2.
Subsequently, in the second study Rhenium Re 188-P2045 will be administered at 40, 50, 75, 85 and up to 100 per cent of the MTD determined in the first study, as a single agent or following 3 daily topotecan treatments (at 1.0 or 1.5 mg/m2) in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Technicium (Tc) Tc99m P2045 scanning.
The overall response and survival rates of patient treated with Rhenium Re188 P2045 when administered as a single dose or following topotecan will be measured.
The change (if any) in SSTR2 expression, as determined by Tc99m P2045 scanning after topotecan administration will also be determined . The correlation of pre-therapy SSTR2 expression (as determined by Tc99m P2045 scan) with overall response and survival rates will be calculated.
- Conditions
- Small Cell Lung Cancer (SCLC), Neuroendocrine (NE) Tumors, Large Cell Neuroendocrine (NE) Tumors
- Being tested
- Rhenium Re 188-P2045
- Keywords
- Lung cancer, Small cell lung cancer, Neuroendocrine tumor, Rhenium, Re 188-P2045
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms, Lung Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhenium Re 188-P2045Drug
Also called Study B
Topotecan at 1.0 mg/m2 or 1.5 mg/m2 for 3 days, followed by single dose of Rhenium Re 188-P2045, at one of the following dosage levels based on the Phase I Maximum Tolerated Dose (MTD): 40% of MTD; 50% of MTD; 75% of MTD; 85% of MTD or 100% of MTD.
| Study group | Role | What they receive |
|---|---|---|
| Topotecan and Rhenium Re 188 P2045 | Experimental | In the phase II portion of this study, patients will be screened using Technicium Tc99m. Eligible, consented patients will receive Topotecan treatment for three days, at doses of either 1.0 mg/m2 or 1.5 mg/m2. They will then receive a single dose of Rhenium Re 188-P2045, at one of the following dosage levels based on the Phase I Maximum Tolerated Dose (MTD): 40% of MTD; 50% of MTD; 75% of MTD; 85% of MTD or 100% of MTD. Receives: Drug: Rhenium Re 188-P2045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Maximum Tolerated Dose (MTD)
To determine, via dose-limiting toxicity (DLT), the maximally tolerated dose (MTD) for Rhenium Re188-P2045 when administered as a single dose in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Tc99m P2045 scanning.
Measured: 28 days
Secondary outcomes (4)
Overall Response Rate (ORR)
To describe the overall response rate (ORR) after treatment with Re188 P2045 when administered either as a single dose (Phase I) or following topotecan (Phase II) in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Tc99m P2045 scanning.
Measured: 5 Years
Progression Free Survival (PFS) Rate
To describe the progression free survival rate (PFS) of survival after treatment with Re188 P2045 when administered as a single dose or following topotecan in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Tc99m P2045 scanning
Measured: 5 years
Change in SSTR2 Expression
To describe the change (if any) in SSTR2 expression, as determined by Tc99m P2045 scanning after topotecan administration.
Measured: 3 Days
Correlation: Pre-therapy SSTR2 Expression vs. ORR and PFS
Calculate potential correlation between pre-therapy SSTR2 expression, as determined by Tc99m P2045 imaging, and patient Overall Response Rate (ORR) up to 5 years post treatment. Calculate potential correlation between pre-therapy SSTR2 expression, as determined by Tc99m P2045 imaging, and patient Progression Free Survival (PFS) up to 5 years post treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJun 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: PI has left the study institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030184
- Sponsor's protocol ID
- INST 1401
- Status last verified
- Oct 2019
- First submitted
- 6 Jan 2014
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Dose Escalation Trial of Rhenium 188-P2045 in Small Cell Lung Cancer and Other Advanced Neuroendocrine Carcinomas as a Single Agent and in Combination With Topotecan
- ClinicalTrials.gov ID
- NCT02030184
- Acronym / sponsor ID
- INST 1401
- Conditions
- Small Cell Lung Cancer (SCLC), Neuroendocrine (NE) Tumors, Large Cell Neuroendocrine (NE) Tumors
- Keywords
- Lung cancer, Small cell lung cancer, Neuroendocrine tumor, Rhenium, Re 188-P2045
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left the study institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 8 Jan 2014 (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.
There are two parts to this trial. The first study will evaluate increasing doses of Re188 P2045 in patients with advanced small cell lung cancer that has recurred after initial therapy or in patients with other advanced neuroendocrine cancers that have progressed after therapy.
Re188 P2045 is designed to attach to type 2 somatostatin receptors that are frequently expressed in those cancers and then the radioactivity from Re188 will kill the cancer cell. Only patients who have cancers that can be seen when Tc99 P2045 is administered (also seeks out the SSTR2, but Tc99 images, but does not treat the cells) will be treated.
Therefore, this approach maximizes the possibility that patients will benefit from treatment in that only those who have cancers that have the target will undergo treatment. The primary purpose of this study will be to determine the highest dose of Re188 P2045 that can be safely administered.
The second study will open after the conclusion of the first. Patients will first undergo the scan with Tc99 P2045 and then be treated with topotecan for three days. Topotecan is a standard chemotherapy drug that is approved for second line therapy for small cell and frequently used for other neuroendocrine cancers. Following that, patients will then be re-evaluated with the Tc99 P2045 scan and if it demonstrates that the tumor is positive for SSTR2, then patients will receive Re188 P2045. The goal of this study is to determine the highest dose of Re188 P2045 that can be safely administered after topotecan as well as to determine if topotecan will increase the chance that the tumor will express SSTR2.
Detailed description
This trial will be conducted patients with small cell lung cancer and other neuroendocrine cancers. These include extrapulmonary small cell, gastrointestinal carcinoid tumors that arise from pulmonary lesions, and large cell neuroendocrine (NE) tumors.
First, the dose-limiting toxicity (DLT) and maximally tolerated dose (MTD) for Rhenium Re188-P2045 alone will be determined when it is administered as a single dose, at 80, 90, 130, 170, 210 or (up to) 250 mCi/m2.
Subsequently, in the second study Rhenium Re 188-P2045 will be administered at 40, 50, 75, 85 and up to 100 per cent of the MTD determined in the first study, as a single agent or following 3 daily topotecan treatments (at 1.0 or 1.5 mg/m2) in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Technicium (Tc) Tc99m P2045 scanning.
The overall response and survival rates of patient treated with Rhenium Re188 P2045 when administered as a single dose or following topotecan will be measured.
The change (if any) in SSTR2 expression, as determined by Tc99m P2045 scanning after topotecan administration will also be determined . The correlation of pre-therapy SSTR2 expression (as determined by Tc99m P2045 scan) with overall response and survival rates will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topotecan and Rhenium Re 188 P2045 | Experimental | Drug: Rhenium Re 188-P2045In the phase II portion of this study, patients will be screened using Technicium Tc99m. Eligible, consented patients will receive Topotecan treatment for three days, at doses of either 1.0 mg/m2 or 1.5 mg/m2. They will then receive a single dose of Rhenium Re 188-P2045, at one of the following dosage levels based on the Phase I Maximum Tolerated Dose (MTD): 40% of MTD; 50% of MTD; 75% of MTD; 85% of MTD or 100% of MTD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age >/=18 years.
- Advanced, metastatic or locally recurrent, incurable neuroendocrine tumors (small cell lung cancer, extrapulmonary small cell lung cancer, large cell neuroendocrine lung carcinoma pulmonary carcinoid, GI carcinoid tumor
- Symptomatic CNS metastases: must have received therapy (surgery, XRT, gamma knife)
- Asymptomatic CNS metastatic disease: discuss with Study Chair.
- Histologically-or cytologically documented disease.
Key exclusion criteria (14 listed)
- Merkel cell carcinoma
- Leptomeningeal disease or carcinomatous meningitis
- Chemotherapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered > 3 weeks earlier.
- If the patient was receiving an oral agent, at least 4 half lives should have elapsed.
- Cannot receive any other investigational agent at the time of registration. At least 3 weeks should have elapsed since administration of an IV investigational agent or 4 half lives for an oral investigational agent.
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 |
|---|---|---|
| Rhenium Re 188-P2045Also: Study BTopotecan at 1.0 mg/m2 or 1.5 mg/m2 for 3 days, followed by single dose of Rhenium Re 188-P2045, at one of the following dosage levels based on the Phase I Maximum Tolerated Dose (MTD): 40% of MTD; 50% of MTD; 75% of MTD; 85% of MTD or 100% of MTD. | Drug | Topotecan and Rhenium Re 188 P2045 |
Primary outcome
Determine Maximum Tolerated Dose (MTD)
Time frame: 28 days
To determine, via dose-limiting toxicity (DLT), the maximally tolerated dose (MTD) for Rhenium Re188-P2045 when administered as a single dose in patients with advanced neuroendocrine tumors and SSTR2 expression as determined by Tc99m P2045 scanning.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: 5 Years
Progression Free Survival (PFS) Rate
Time frame: 5 years
Change in SSTR2 Expression
Time frame: 3 Days
Correlation: Pre-therapy SSTR2 Expression vs. ORR and PFS
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rhenium Re 188-P2045 in people with Small Cell Lung Cancer (SCLC) and Neuroendocrine (NE) Tumors, run by University of Maryland, Baltimore 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 17 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Oct 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Determine Maximum Tolerated Dose (MTD) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2019.