Adrenocortical CarcinomaEarly Phase 1NCT00436410
Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer
A Early Phase 1 study testing colloidal gold-bound tumor necrosis factor, electron microscopy and pharmacological study in people with Adrenocortical Carcinoma and Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial summary
RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may help doctors learn how tumor necrosis factor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer
- What is being tested?
- colloidal gold-bound tumor necrosis factor, electron microscopy and pharmacological study
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2006to Aug 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary or metastatic malignancy, including any of the following:
- Colorectal cancer
- Hepatocellular cancer
- Pancreatic exocrine cancer
- Pancreatic endocrine cancer
- Breast cancer
- Melanoma
- Sarcoma
- Primary adrenal tumors
- Renal cell carcinoma
- Ovarian cancer
- Adenocarcinoma of gastrointestinal origin
- Peritoneal mesothelioma
- Clinical indication for surgical resection
- No known brain metastases
- Previously treated brain metastases with no evidence of recurrence allowed
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy ≥ 5 months
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.5 mg/dL
- ALT and AST ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Hemoglobin ≥ 9.0 g/dL
- Ejection fraction ≥ 45% by echocardiogram, thallium stress test, or MUGA (for patients with prior cardiovascular disease)
- FEV_1 OR DLCO > 30% of predicted (for patients with prior pulmonary disease)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active bacterial infection
- Localized chronic infection (e.g., mild acne, tinea pedis) allowed
- No known bleeding disorder
- No other serious illness including, but not limited to, any of the following:
- Unstable angina
- Severe oxygen-dependent chronic obstructive pulmonary disease
- End-stage liver disease
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy, including cytotoxic drugs, radiotherapy, surgery, or other anticancer modalities
- More than 3 weeks since prior biologic therapy or cytotoxic agents (6 weeks for nitrosoureas) and recovered
- No concurrent treatment in a protocol for which patient is being evaluated for response
- No other concurrent anticancer treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NCI - Center for Cancer Research-Medical Oncology
Bethesda, Maryland, 20892-1182
NCI - Surgery Branch
Bethesda, Maryland, 20892-1201
About this study
Official title: An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects With Primary and Metastatic Cancer Undergoing Surgical Resection
RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may help doctors learn how tumor necrosis factor works in tumor tissue and healthy tissue.
PURPOSE: This clinical trial is studying tumor necrosis factor in patients undergoing surgery for primary cancer or metastatic cancer .
Read the detailed description
OBJECTIVES:
Primary
- Determine the tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor in patients with primary or metastatic cancer undergoing surgery.
Secondary
- Determine, by histological examination of resected tumor tissue, the acute antitumor effects of this treatment in these patients.
- Determine the long-term toxicities of this treatment in these patients.
- Determine the response to this treatment in these patients.
OUTLINE: This is a cohort study. Patients are stratified according to disease type (colorectal cancer vs hepatocellular cancer vs pancreatic exocrine cancer vs pancreatic endocrine cancer vs breast cancer vs melanoma vs primary adrenal tumors vs renal cell carcinoma).
Patients receive colloidal gold-bound tumor necrosis factor IV over 15-30 seconds 12-78 hours prior to surgery. Patients then undergo standard-care surgery.
Tumor and normal tissues are removed during surgery for analysis of antitumor effects and tissue distribution of colloidal gold-bound tumor necrosis factor by electron microscopy.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.
- Conditions
- Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer, Gastrointestinal Cancer, Kidney Cancer, Liver Cancer
- Being tested
- colloidal gold-bound tumor necrosis factor, electron microscopy, pharmacological study, conventional surgery
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adult primary hepatocellular carcinoma, stage IV pancreatic cancer, male breast cancer, stage IV breast cancer, stage IV melanoma, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent breast cancer, recurrent adrenocortical carcinoma, stage I adrenocortical carcinoma, stage II adrenocortical carcinoma, stage III adrenocortical carcinoma, stage IV adrenocortical carcinoma, recurrent colon cancer, stage I colon cancer
- Medical subject headings
- Adrenocortical Carcinoma, Breast Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, Kidney Neoplasms, Liver Neoplasms, Melanoma, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colloidal gold-bound tumor necrosis factorBiological
electron microscopyOther
conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues
Secondary outcomes (2)
Acute antitumor activity of treatment
Long-term toxicity of treatment as assessed by CTCAE v3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startDec 2006
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- 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
- Treatment
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven A. Rosenberg, MD, PhD, Study chair, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436410
- Sponsor's protocol ID
- 070043
- Other IDs
- 07-C-0043, NCI-P6066, CYT-NCI-07-C-0043, CDR0000529849
- Status last verified
- May 2012
- First submitted
- 15 Feb 2007
- Last updated
- 2 May 2012
- Results posted
- No
Publications
Kesharwani P, Ma R, Sang L, Fatima M, Sheikh A, Abourehab MAS, Gupta N, Chen ZS, Zhou Y. Gold nanoparticles and gold nanorods in the landscape of cancer therapy. Mol Cancer. 2023 Jun 21;22(1):98. doi: 10.1186/s12943-023-01798-8.
PubMed 37344887
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Tissue Distribution and the Selective Tumor Trafficking of TNF-Bound Colloidal Gold (CYT-6091) Following Intravenous Administration in Subjects With Primary and Metastatic Cancer Undergoing Surgical Resection
- ClinicalTrials.gov ID
- NCT00436410
- Acronym / sponsor ID
- 070043
- Conditions
- Adrenocortical Carcinoma, Breast Cancer, Colorectal Cancer, Gastrointestinal Cancer, Kidney Cancer, Liver Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, adult primary hepatocellular carcinoma, stage IV pancreatic cancer, male breast cancer, stage IV breast cancer, stage IV melanoma, stage I breast cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Feb 2007 (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.
RATIONALE: Biological therapies, such as tumor necrosis factor, may stimulate the immune system in different ways and stop tumor cells from growing. Studying tumor necrosis factor in samples of tumor tissue and healthy tissue from patients with cancer in the laboratory may help doctors learn how tumor necrosis factor works in tumor tissue and healthy tissue.
PURPOSE: This clinical trial is studying tumor necrosis factor in patients undergoing surgery for primary cancer or metastatic cancer .
Detailed description
OBJECTIVES:
Primary
- Determine the tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor in patients with primary or metastatic cancer undergoing surgery.
Secondary
- Determine, by histological examination of resected tumor tissue, the acute antitumor effects of this treatment in these patients.
- Determine the long-term toxicities of this treatment in these patients.
- Determine the response to this treatment in these patients.
OUTLINE: This is a cohort study. Patients are stratified according to disease type (colorectal cancer vs hepatocellular cancer vs pancreatic exocrine cancer vs pancreatic endocrine cancer vs breast cancer vs melanoma vs primary adrenal tumors vs renal cell carcinoma).
Patients receive colloidal gold-bound tumor necrosis factor IV over 15-30 seconds 12-78 hours prior to surgery. Patients then undergo standard-care surgery.
Tumor and normal tissues are removed during surgery for analysis of antitumor effects and tissue distribution of colloidal gold-bound tumor necrosis factor by electron microscopy.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| colloidal gold-bound tumor necrosis factor | Biological | – |
| electron microscopy | Other | – |
| pharmacological study | Other | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor
Comparison of the impact of distribution time and histology on accumulation of treatment particles in tumor vs normal tissues
2 secondary outcomes
Acute antitumor activity of treatment
Long-term toxicity of treatment as assessed by CTCAE v3.0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
- Derived from this study: PubMed 37344887Kesharwani P, Ma R, Sang L, Fatima M, Sheikh A, Abourehab MAS, Gupta N, Chen ZS, Zhou Y. Gold nanoparticles and gold nanorods in the landscape of cancer therapy. Mol Cancer. 2023 Jun 21;22(1):98. doi: 10.1186/s12943-023-01798-8.
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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.
Steven A. Rosenberg, MD, PhD study chair
NCI - Surgery Branch
2 sites 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 colloidal gold-bound tumor necrosis factor, electron microscopy and pharmacological study in people with Adrenocortical Carcinoma and Breast Cancer, run by National Institutes of Health Clinical Center (CC) at 2 sites 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?
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: finished, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumor tissue and normal tissue distribution of colloidal gold-bound tumor necrosis factor. The study lists 2 primary outcomes in all. 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 NCT00436410, which also lists 1 linked publication.
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 2 May 2012.