Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00019331 History of Changes |
| Obsolete Identifiers: | NCT00001581 |
| Other Study ID Numbers: | CDR0000065656, NCI-97-C-0141F, NCI-T96-0078 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Colorectal Neoplasms Head and Neck Neoplasms Liver Neoplasms Lung Neoplasms Melanoma Pancreatic Neoplasms Neoplasms, Germ Cell and Embryonal Adenoma Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases |
Genital Diseases, Female Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Liver Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors |
ClinicalTrials.gov processed this record on May 19, 2013