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| Sponsor: | 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 |
Biological: aldesleukin Biological: ras peptide cancer vaccine Biological: sargramostim Drug: DetoxPC |
Phase II |
| 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 | |
| Study Chair: | Barry L. Gause, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000065656, NCI-97-C-0141F, NCI-T96-0078 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00019331 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer recurrent non-small cell lung cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer recurrent colon cancer extensive stage small cell lung cancer recurrent small cell lung cancer advanced adult primary liver cancer recurrent adult primary liver cancer stage IV endometrial carcinoma recurrent endometrial carcinoma stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor stage IV papillary thyroid cancer |
stage IV follicular thyroid cancer thyroid gland medullary carcinoma anaplastic thyroid cancer recurrent thyroid cancer stage IV melanoma recurrent melanoma stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary adult primary hepatocellular carcinoma pulmonary carcinoid tumor stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip stage IV verrucous carcinoma of the oral cavity |
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Thoracic Neoplasms Anti-Infective Agents Liver Diseases Antineoplastic Agents Gastrointestinal Diseases Pancreatic Neoplasms Neoplasms, Nerve Tissue Colonic Diseases Urogenital Neoplasms Rectal Diseases Melanoma Genital Diseases, Female Liver Neoplasms Endometrial Neoplasms Neoplasms by Site |
Anti-Retroviral Agents Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Uterine Neoplasms Nevi and Melanomas Endocrine Gland Neoplasms Respiratory Tract Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Digestive System Neoplasms Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases |