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| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019331 |
Purpose
RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more effective treatment for solid tumors.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 and/or sargramostim in treating adults who have metastatic solid tumors.
| Condition | Intervention | Phase |
|
Colorectal Cancer Endometrial Cancer Head and Neck Cancer Liver Cancer Lung Cancer Melanoma (Skin) Pancreatic Cancer Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific |
Drug: DetoxPC Drug: aldesleukin Drug: ras peptide cancer vaccine Drug: sargramostim |
Phase II |
| MedlinePlus related topics: | Cancer Colorectal Cancer Head and Neck Cancer Liver Cancer Lung Cancer Melanoma Pancreatic Cancer Thyroid Cancer |
| Drug Information available for: | Aldesleukin Sargramostim Granulocyte-macrophage colony-stimulating factor Thyroid Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors |
| Study Start Date: | October 1997 |
OBJECTIVES:
OUTLINE: Patients are assigned to one of three treatment groups.
In all groups, patients receive up to 15 vaccinations in the absence of disease progression.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A maximum of 60 patients (20 per treatment group) will be accrued for this study within 2-4 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Ras mutations must be one of the following point mutations at codon 12:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Immunologic:
No prior autoimmune disease, including the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Study Chair: | Barry L. Gause, MD | NCI - Center for Cancer Research-Medical Oncology |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000065656, NCI-97-C-0141F, NCI-T96-0078 |
| First Received: | July 11, 2001 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00019331 |
| Health Authority: | United States: Federal Government |
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