Breast CancerPhase 2NCT00019084
Vaccine Therapy and Biological Therapy in Treating Patients With Advanced Cancer
A Phase 2 study testing aldesleukin, mutant p53 peptide pulsed dendritic cell vaccine and ras peptide cancer vaccine in people with Breast Cancer and Cervical Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Colorectal Cancer
- What is being tested?
- aldesleukin, mutant p53 peptide pulsed dendritic cell vaccine and ras peptide cancer vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 1996to May 2003
- 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 diagnosed advanced cancer considered incurable by standard therapies and expressing mutant p53 or ras, e.g.: Lung Pancreatic Breast Colon Cervical Ovarian p53 or ras mutation by point mutation, insertion, or deletion in protein-coding sequence Tumor tissue required for p53 or ras mutation determination (paraffin block or fresh tissue) Availability of tumor tissue for cell line preparation and of tumor or lymph node tissues for tumor-infiltrating lymphocyte expansion desired No history of 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/mm3 Lymphocyte count at least 800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT no greater than 4 times normal No hepatitis B or C Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within 6 months No New York Heart Association class III or IV heart disease Immunologic: HIV negative No autoimmune disease, e.g.: Systemic lupus erythematosus Multiple sclerosis Ankylosing spondylitis Responsive to skin antigens Other: No weight loss of greater than 20% in the last 6 months No active infection requiring antibiotics No active second malignancy except basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: 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: Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VACCINE THERAPY WITH TUMOR SPECIFIC MUTATED P53 OR RAS PEPTIDES ALONE OR IN COMBINATION WITH CELLULAR IMMUNOTHERAPY WITH PEPTIDE ACTIVATED LYMPHOCYTES (PAL CELLS) ALONG WITH SUBCUTANEOUS IL-2
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for advanced cancer.
PURPOSE: Phase II trial to study the effectiveness of a vaccine made with the patients' white blood cells mixed with tumor proteins in treating patients who have advanced cancer.
Read the detailed description
OBJECTIVES: I. Determine whether endogenous cellular immunity to a particular tumor-specific mutated p53 or ras protein is present in patients with tumors expressing mutant p53 or ras. II. Determine whether vaccination with antigen-presenting cells pulsed in vitro with synthetic peptide corresponding to the tumor's p53 or ras mutation in the presence of sargramostim (GM-CSF) can induce or boost patient cellular immunity to the mutated peptide in this patient population. III. Assess the type and characteristics of the cellular immunity generated. IV. Determine whether in vivo-primed T-cells generated against the p53 or ras mutation, expanded in vitro with corresponding peptide, and infused with subcutaneous interleukin-2 can enhance the activity of specific cytotoxic T-lymphocyte immune response and/or tumor response in these patients.
OUTLINE: Patients are assigned to 1 of 2 treatment regimens. The first 5 patients accrued are assigned to Regimen A. Three weeks after all 5 patients are enrolled, additional patients are accrued and assigned to Regimen B. All patients undergo peptide hypersensitivity testing with the peptide they will be treated with prior to each vaccination. Regimen A: Two days prior to each vaccination, peripheral blood mononuclear cells (PBMC) are harvested. PBMC are incubated for 48 hours with either patient-specific mutant p53 or ras peptide fragments and sargramostim (GM-CSF). The antigen-presenting cells (APC) are irradiated prior to use. APC are reinfused on day 0. Treatment repeats after 3 weeks and then every 6 weeks for a total of 4 vaccinations. Regimen B: Patients are vaccinated with APC as in Regimen A. PBMC are harvested prior to the first APC vaccination and 1 week after the second, third, and fourth APC vaccinations. PBMC are incubated for 7 days with either peptide the patient was vaccinated with (mutant p53 or ras peptide fragments) and interleukin-2 (IL-2). The peptide-activated lymphocytes (PAL) are reinfused over 1 hour 2 weeks after each APC vaccination. Patients receive IL-2 subcutaneously 5 days a week for 2 weeks beginning 4 hours after each PAL infusion. Patients in both regimens with stable or responding disease continue treatment every 6 weeks. Patients achieving complete response continue treatment for up to 1 additional year. Patients are followed at 1 and 2 months.
PROJECTED ACCRUAL: A maximum of 70 patients (5 per Regimen A, 28-65 per Regimen B) will be accrued for this study.
- Conditions
- Breast Cancer, Cervical Cancer, Colorectal Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Being tested
- aldesleukin, mutant p53 peptide pulsed dendritic cell vaccine, ras peptide cancer vaccine, sargramostim, therapeutic autologous lymphocytes
- Keywords
- stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, recurrent non-small cell lung cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, recurrent colon cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage IV non-small cell lung cancer, stage IV pancreatic cancer
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
mutant p53 peptide pulsed dendritic cell vaccineBiological
ras peptide cancer vaccineBiological
sargramostimBiological
therapeutic autologous lymphocytesBiological
therapeutic tumor infiltrating lymphocytesBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2003 (estimated)
- Study startFeb 1996
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Samir N. Khleif, MD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019084
- Sponsor's protocol ID
- CDR0000064192
- Other IDs
- NCI-95-C-0105A, NCI-T94-0096N
- Status last verified
- Apr 2007
- 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 P53 OR RAS PEPTIDES ALONE OR IN COMBINATION WITH CELLULAR IMMUNOTHERAPY WITH PEPTIDE ACTIVATED LYMPHOCYTES (PAL CELLS) ALONG WITH SUBCUTANEOUS IL-2
- ClinicalTrials.gov ID
- NCT00019084
- Acronym / sponsor ID
- CDR0000064192
- Conditions
- Breast Cancer, Cervical Cancer, Colorectal Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer
- Keywords
- stage IV colon cancer, stage IV breast cancer, recurrent breast cancer, recurrent non-small cell lung cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, recurrent colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 1996
- Study completion
- May 2003 (actual)
- First posted
- 23 May 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 person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for advanced cancer.
PURPOSE: Phase II trial to study the effectiveness of a vaccine made with the patients' white blood cells mixed with tumor proteins in treating patients who have advanced cancer.
Detailed description
OBJECTIVES: I. Determine whether endogenous cellular immunity to a particular tumor-specific mutated p53 or ras protein is present in patients with tumors expressing mutant p53 or ras. II. Determine whether vaccination with antigen-presenting cells pulsed in vitro with synthetic peptide corresponding to the tumor's p53 or ras mutation in the presence of sargramostim (GM-CSF) can induce or boost patient cellular immunity to the mutated peptide in this patient population. III. Assess the type and characteristics of the cellular immunity generated. IV. Determine whether in vivo-primed T-cells generated against the p53 or ras mutation, expanded in vitro with corresponding peptide, and infused with subcutaneous interleukin-2 can enhance the activity of specific cytotoxic T-lymphocyte immune response and/or tumor response in these patients.
OUTLINE: Patients are assigned to 1 of 2 treatment regimens. The first 5 patients accrued are assigned to Regimen A. Three weeks after all 5 patients are enrolled, additional patients are accrued and assigned to Regimen B. All patients undergo peptide hypersensitivity testing with the peptide they will be treated with prior to each vaccination. Regimen A: Two days prior to each vaccination, peripheral blood mononuclear cells (PBMC) are harvested. PBMC are incubated for 48 hours with either patient-specific mutant p53 or ras peptide fragments and sargramostim (GM-CSF). The antigen-presenting cells (APC) are irradiated prior to use. APC are reinfused on day 0. Treatment repeats after 3 weeks and then every 6 weeks for a total of 4 vaccinations. Regimen B: Patients are vaccinated with APC as in Regimen A. PBMC are harvested prior to the first APC vaccination and 1 week after the second, third, and fourth APC vaccinations. PBMC are incubated for 7 days with either peptide the patient was vaccinated with (mutant p53 or ras peptide fragments) and interleukin-2 (IL-2). The peptide-activated lymphocytes (PAL) are reinfused over 1 hour 2 weeks after each APC vaccination. Patients receive IL-2 subcutaneously 5 days a week for 2 weeks beginning 4 hours after each PAL infusion. Patients in both regimens with stable or responding disease continue treatment every 6 weeks. Patients achieving complete response continue treatment for up to 1 additional year. Patients are followed at 1 and 2 months.
PROJECTED ACCRUAL: A maximum of 70 patients (5 per Regimen A, 28-65 per Regimen B) will be accrued for this study.
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 | – |
| mutant p53 peptide pulsed dendritic cell vaccine | Biological | – |
| ras peptide cancer vaccine | Biological | – |
| sargramostim | Biological | – |
| therapeutic autologous lymphocytes | Biological | – |
| therapeutic tumor infiltrating lymphocytes | Biological | – |
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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Samir N. Khleif, 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, mutant p53 peptide pulsed dendritic cell vaccine and ras peptide cancer vaccine in people with Breast Cancer and Cervical 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.