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

This study has been completed.

Sponsored by: 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   

ChemIDplus related topics:   Aldesleukin    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Thyroid    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 1997

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019331

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

Investigators
Study Chair:     Barry L. Gause, MD     National Cancer Institute (NCI)    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065656, NCI-97-C-0141F, NCI-T96-0078
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00019331
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

Study placed in the following topic categories:
Thoracic Neoplasms
Liver Diseases
Carcinoma, Hepatocellular
Pancreatic Neoplasms
Colonic Diseases
Urogenital Neoplasms
Rectal Diseases
Endometrial Neoplasms
Carcinoma, Adenoid Cystic
Lung Neoplasms
Metastatic squamous neck cancer with occult primary
Neuroepithelioma
Laryngeal carcinoma
Salivary Gland Diseases
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Carcinoma, Basal Cell
Testicular Neoplasms
Thyroid cancer, papillary
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Aldesleukin
Lung Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Testicular cancer

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Antineoplastic Agents
Neoplasms, Nerve Tissue
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Therapeutic Uses
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 05, 2008




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