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Trial record 1 of 1 for:    NCI97C0141
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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. Identifier: NCT00019331
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment 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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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
Actual Study Completion Date : May 2007

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00019331

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Barry L. Gause, MD National Cancer Institute (NCI)

Layout table for additonal information Identifier: NCT00019331    
Obsolete Identifiers: NCT00001581
Other Study ID Numbers: CDR0000065656
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: April 2004
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:
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Lung Neoplasms
Pancreatic Neoplasms
Head and Neck Neoplasms
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Endometrial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Digestive System Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female