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NCT00001703 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy With Tumor Specific Mutated VHL Peptides in Adult Cancer Patients With Renal Cell Carcinoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00001703: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00001703 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001703, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
About 27,000 new cases of renal cell carcinoma (RCC) are diagnosed every year in the United States. 11,000 of these cases will die from the disease. More than half of patients present with advanced or metastatic disease for which chemotherapy plays a very limited role. Therefore, development of another therapeutic approach is needed. Cancers in humans are commonly associated with mutations in dominant and recessive oncogenes. These genes produce mutated proteins that are unique to cancer cells. Von Hipple-Lindau (VHL) gene which is associated with the development of the VHL disease, has been recently mapped and cloned, and it is found to be mutated in 57% of sporadic renal cell carcinomas. Data in mice have shown the generation of major histocompatibility complex (MHC) restricted cytotoxic T lymphocyte (CTL) that are capable of detecting endogenous cytoplasmic peptide derived from mutated oncogenes. In addition, we have recently demonstrated, by conducting different phase I clinical trials in which we vaccinate cancer patients with mutated Ras or p53 peptides corresponding to the abnormality patients harbor in their tumors, that in some patients we can generate immunological responses represented by the generation of lymphocytes (CD4+ and/or CD8+). In the current study, we would like to extend our observations to test whether VHL tumor suppressor protein can be immunologically targeted by vaccination. We have identified specific epitopes along the amino acid sequence of the VHL protein, which represent known specific human leukocyte antigen (HLA) class-I binding motifs. These amino acids stretches in the VHL protein correspond to the area of the point mutation hot spots. Therefore, we propose to treat patients with sporadic RCC who carry VHL mutations in their tumors with corresponding mutant VHL peptide vaccination. This vaccination will be done either by using pulsed-autologous peripheral mononuclear cells with the peptides, or peptides administered subcutaneousl
Interventions
- BIOLOGICAL incomplete Freund's adjuvant
- BIOLOGICAL von Hippel-Lindau peptide vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 1998-08 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001703
The ClinicalTrials.gov registry entry for NCT00001703 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which incomplete Freund's adjuvant is the first listed.
NCT00001703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001703 about?
NCT00001703 is a clinical study titled "Vaccine Therapy With Tumor Specific Mutated VHL Peptides in Adult Cancer Patients With Renal Cell Carcinoma". About 27,000 new cases of renal cell carcinoma (RCC) are diagnosed every year in the United States. 11,000 of these cases will die from the disease. More than half of patients present with advanced or metastatic disease for which chemotherapy plays a very limited role. Therefore, development of anot...
What is the current status of trial NCT00001703?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 1998-08. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00001703?
The interventions under investigation include: incomplete Freund's adjuvant (BIOLOGICAL), von Hippel-Lindau peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001703?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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