AzTrials
AzTrials

Recurrent Colon CancerPhase 1NCT00019006

Vaccine Therapy in Treating Patients With Colon, Pancreatic, or Lung Cancer

A Phase 1 study testing Detox-B adjuvant and ras peptide cancer vaccine in people with Recurrent Colon Cancer and Extensive Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Vaccines made from mutated ras peptides may make the body build an immune response to and kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of a vaccine containing mutated ras peptides and an immune adjuvant in treating patients who have colon, pancreatic, or lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Detox-B adjuvant and ras peptide cancer vaccine
Type of treatment
Vaccines
How many people
Not given
Where
1 siteUnited States
Study dates
Mar 1995to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult
  1. Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society
  • Demonstration of CD1a antigenic determinants on the surface of lesional cells (by immunocytology or immunohistology) or Birbeck granules in lesional cells by electron microscopy
  1. Considered at risk or low risk according to the following criteria:
  2. Multi-system at risk disease, defined as involvement of one or more risk organs (i.e., hematopoietic system, liver, spleen, or lungs)
  • No single-system lung involvement
  1. Multi-system low-risk disease
  • Multiple organs involved but without involvement of risk organs
  1. Single-system disease
  • Multifocal bone disease (i.e., lesions in 2 or more different bones)
  • Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension
  • Vault lesions are not regarded as CNS-risk lesions

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically documented solid tumor potentially expressing mutant ras Stage II/III adenocarcinoma of the lung following surgery or radiotherapy Limited or extensive small cell lung cancer in complete remission Dukes' C colorectal cancer following appropriate adjuvant chemotherapy Fully resected recurrent colorectal carcinoma Fully resected pancreatic carcinoma Tumor tissue available for determination of ras mutation Paraffin block or fresh tissue Specific point mutation in codon 12 required, which includes: Glycine to cysteine Glycine to aspartic acid Glycine to valine Tumor tissue available for preparation of a tumor cell line and tumor or lymph node tissue for expansion of tumor infiltrating lymphocytes for in vitro laboratory studies preferred No history of CNS metastases --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: At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Not specified --Patient Characteristics-- Age: Over 18 Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Lymphocyte count at least 600/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT and AST no greater than 4 times normal Hepatitis B and C surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active ischemic heart disease (New York Heart Association class III/IV) No myocardial infarction within 6 months No history of arrhythmia No clinical symptoms suggesting cardiac insufficiency Pulmonary: No clinical symptoms suggesting pulmonary insufficiency Immunologic: Responsive to anergy skin testing with mumps, trichophyton, or candida antigens HIV negative No autoimmune disease, e.g.: Systemic lupus erythematosus Multiple sclerosis Ankylosing spondylitis Other: No active infection requiring antibiotics No history of malignancy except curatively treated basal cell skin carcinoma or curatively treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medicine Branch

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase I Pilot Study of Vaccine Therapy With Tumor-Specific Mutated Ras Peptides in the Adjuvant Setting in Patients With Colorectal, Pancreatic, or Lung Cancer

RATIONALE: Vaccines made from mutated ras peptides may make the body build an immune response to and kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of a vaccine containing mutated ras peptides and an immune adjuvant in treating patients who have colon, pancreatic, or lung cancer.

Read the detailed description

OBJECTIVES: I. Determine whether endogenous cellular or humoral immunity to a tumor-specific mutated ras protein is present in patients with colorectal, pancreatic, or lung cancer.

II. Determine whether vaccination with a synthetic peptide corresponding to the tumor's ras mutation combined with Detox-B adjuvant can induce or boost cellular immunity to that particular mutation in this patient population.

III. Determine the type and characteristics of any cellular immunity generated in these patients treated with this regimen.

IV. Determine the tolerance and toxicity spectra of such peptides given with Detox-B adjuvant in these patients.

  1. Determine the immune response associated with each peptide dose in these patients.

VI. Assess any tumor response that may occur with treatment in these patients treated with this regimen.

PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive tumor-specific mutated ras peptide combined with Detox-B adjuvant subcutaneously monthly for 3 months. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease or with a specific immunologic response may receive 3 additional monthly vaccinations.

Cohorts of 3-6 patients receive escalating doses of tumor-specific mutated ras peptide combined with Detox-B adjuvant until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL:

A total of 33 patients (12 in the adjuvant setting) will be accrued for this study within 12 months.

Being tested
Detox-B adjuvant, ras peptide cancer vaccine
Keywords
adult solid tumor, body system/site cancer, cancer, colon cancer, colorectal cancer, extensive stage small cell lung cancer, gastrointestinal cancer, genetic condition, limited stage small cell lung cancer, lung cancer, non-small cell lung cancer, pancreatic cancer, rectal cancer, recurrent colon cancer, recurrent pancreatic cancer, recurrent rectal cancer, small cell lung cancer, solid tumor, stage I pancreatic cancer, stage II non-small cell lung cancer
Medical subject headings
Colonic Neoplasms, Pancreatic Neoplasms, Rectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, Genetic Diseases, Inborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Detox-B adjuvantDrug

  • ras peptide cancer vaccineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2007 (estimated)
  2. Study startMar 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019006
Sponsor's protocol ID
CDR0000063475
Other IDs
NCI-94-C-0096D, NCI-T93-0152N
Status last verified
Mar 2024
First submitted
1 Mar 2007
Last updated
4 Mar 2024
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Detox-B adjuvant and ras peptide cancer vaccine in people with Recurrent Colon Cancer and Extensive Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in