Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients. Determine whether vaccination with synthetic peptides corresponding to the tumor's ras mutation with DetoxPC adjuvant, interleukin-2 (IL-2), and/or sargramostim (GM-CSF) can induce or boost a patient's cellular immunity to that particular mutation. Determine the type and characteristics of the cellular immune response generated. Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 and/or GM-CSF. Correlate immune response with tumor response in patients treated with these regimens. OUTLINE: Patients are assigned to one of three treatment groups. Group I (closed to accrual 6/4/01): Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously (SC) once every 5 weeks for 3 courses. Beginning 4 days after vaccination, patients receive interleukin-2 (IL-2) SC 5 days a week for 2 weeks. Group II (closed to accrual 6/4/01): Patients receive sargramostim (GM-CSF) SC daily beginning 1 day prior to the vaccination and continuing for 4 days. Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2. Patients are vaccinated once every 4 weeks for 3 courses. Group III: Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II. 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.

Official Title
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Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors

Conditions
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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

Intervention / Treatment
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* Biological: aldesleukin
* Biological: ras peptide cancer vaccine
* Biological: sargramostim
* Drug: DetoxPC


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed solid tumors potentially expressing mutant ras, including colon, lung, pancreas, thyroid, endometrial, head and neck, testicular, hepatocellular, and melanoma Ras mutations must be one of the following point mutations at codon 12: Glycine to cysteine Glycine to aspartic acid Glycine to valine Metastatic disease for which no known chemotherapy or radiotherapy would increase survival Tumor tissue must be available for determination of ras mutation No prior CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 4 times normal No hepatitis B or C infection Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemic heart disease (New York Heart Association class III or IV) No myocardial infarction within the past 6 months No history of congestive heart failure, ventricular arrhythmias, or other arrhythmias requiring therapy Immunologic: No prior allergy to eggs No prior autoimmune disease, including the following: Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma Myasthenia gravis Goodpasture syndrome Addison's disease, Hashimoto's thyroiditis, or active Graves' disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer No active infection requiring antibiotics No medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior steroids and recovered Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: ras peptide cancer vaccine|nan|
|Biological: sargramostim|nan|
|Drug: DetoxPC|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, insular thyroid cancer, recurrent salivary gland cancer, stage IV salivary gland cancer, stage IV pancreatic cancer