Colorectal CancerPhase 2NCT00019331
Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
A Phase 2 study testing aldesleukin, ras peptide cancer vaccine and sargramostim in people with Colorectal Cancer and Endometrial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Endometrial Cancer, Head and Neck Cancer
- What is being tested?
- aldesleukin, ras peptide cancer vaccine and sargramostim
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1997to May 2007
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Endometrial Cancer, Head and Neck Cancer, Liver Cancer, Lung Cancer, Melanoma (Skin)
- Being tested
- aldesleukin, ras peptide cancer vaccine, sargramostim, DetoxPC
- Keywords
- 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
- Medical subject headings
- Colorectal Neoplasms, Endometrial Neoplasms, Head and Neck Neoplasms, Liver Neoplasms, Lung Neoplasms, Melanoma, Pancreatic Neoplasms, Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
ras peptide cancer vaccineBiological
sargramostimBiological
DetoxPCDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 1997
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Barry L. Gause, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019331
- Sponsor's protocol ID
- CDR0000065656
- Other IDs
- NCI-97-C-0141F, NCI-T96-0078
- Status last verified
- Apr 2004
- First submitted
- 11 Jul 2001
- Last updated
- 20 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00019331
- Acronym / sponsor ID
- CDR0000065656
- Conditions
- Colorectal Cancer, Endometrial Cancer, Head and Neck Cancer, Liver Cancer, Lung Cancer, Melanoma (Skin)
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 1997
- Study completion
- May 2007 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukin | Biological | – |
| ras peptide cancer vaccine | Biological | – |
| sargramostim | Biological | – |
| DetoxPC | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry L. Gause, MD study chair
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin, ras peptide cancer vaccine and sargramostim in people with Colorectal Cancer and Endometrial 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 20 Jun 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 20 Jun 2013.