cropped color_logo_with_background.png

Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer

Study Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Vaccines made from a person's white blood cells and tumor cells 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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and vaccine therapy followed by bone marrow or peripheral stem cell transplantation and interleukin-2 in treating patients who have recurrent or refractory brain cancer.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 65 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed active recurrent or refractory primary high-grade brain tumor.
  • - Tumor must be surgically accessible.
  • - Bidimensionally measurable disease by clinical exam, CT scan, or x-ray.
  • - Disease must be outside a previously irradiated field or have progressed or developed after radiotherapy.
  • - Previously treated metastatic bony lesions are not considered measurable.
  • - No previously irradiated metastatic disease site unless no response or clear progression on imaging.
PATIENT CHARACTERISTICS: Age:
  • - 65 and under.
Performance status:
  • - CALGB 0-2.
Life expectancy:
  • - More than 3 months.
Hematopoietic:
  • - Absolute neutrophil count greater than 1,500/mm^3.
  • - Platelet count greater than 100,000/mm^3.
Hepatic:
  • - Liver function less than 2.5 times normal unless due to disease.
  • - No active hepatitis B or C.
Renal:
  • - Creatinine less than 1.5 mg/dL.
  • - Creatinine clearance greater than 60 mL/min.
Cardiovascular:
  • - Left ventricular ejection fraction greater than 50% by MUGA or 2-D echocardiogram.
  • - Electrocardiogram normal.
Pulmonary:
  • - FEV1 and DLCO greater than 50% predicted OR.
  • - Clearance by pulmonologist.
Other:
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - HIV negative.
  • - No serious underlying co-morbid disease or other medical or psychiatric factor that would preclude study.
  • - Able to be weaned off steroids after surgery.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - Not specified.
Chemotherapy:
  • - Recovered from prior conventional chemotherapy.
Endocrine therapy:
  • - No concurrent steroid therapy for mass effect.
Radiotherapy:
  • - See Disease Characteristics.
  • - Recovered from prior conventional radiotherapy.
Surgery: - See Disease Characteristics

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00014573
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Barbara Ann Karmanos Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Esteban Abella, MD
Principal Investigator Affiliation Barbara Ann Karmanos Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by autologous tumor cell vaccine and sargramostim (GM-CSF) followed by high-dose chemotherapy with cisplatin, cyclophosphamide, and carmustine, autologous bone marrow or peripheral blood stem cell transplantation, and interleukin-2 in patients with recurrent or refractory primary high-grade brain tumors.
  • - Determine the safety and toxicity of this regimen in these patients.
  • - Determine if a specific quantitative cellular response can be elicited in patients treated with this regimen.
OUTLINE: After partial surgical resection of tumor, patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until peripheral blood stem cell (PBSC) or bone marrow collection is completed. After the collection of PBSC or bone marrow, patients receive autologous tumor cell vaccine and sargramostim (GM-CSF) SC once every 2 weeks for up to 5 vaccinations. Two weeks after the last vaccination, patients undergo a second leukapheresis to collect lymphocytes. After completion of the second leukapheresis, patients receive high-dose chemotherapy comprising cisplatin IV continuously over 24 hours on day -5, cyclophosphamide IV over 1 hour on days -5, -4, and -3, and carmustine IV over 2 hours on day -2. Patients undergo autologous bone marrow or PBSC transplantation on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover. Approximately 12 weeks after bone marrow or PBSC transplantation, patients receive autologous lymphocytes IV over 2-5 hours. Patients also receive interleukin-2 IV once every other day for 10 days. Patients are followed at 18, 24, 36, 40, and 52 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379