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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00019331
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

July 11, 2001
January 27, 2003
June 20, 2013
October 1997
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Complete list of historical versions of study NCT00019331 on ClinicalTrials.gov Archive Site
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Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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May 2007
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  • 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



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months


  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 4 times normal
  • No hepatitis B or C infection


  • Creatinine no greater than 2.0 mg/dL


  • 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


  • 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


  • 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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior steroids and recovered


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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National Cancer Institute (NCI)
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Study Chair: Barry L. Gause, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP