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Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors


Phase 2
N/A
65 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Esteban Abella, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068559

NCT ID:

NCT00014573

Start Date:

August 1998

Completion Date:

October 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood infratentorial ependymoma
  • childhood supratentorial ependymoma
  • childhood central nervous system germ cell tumor
  • recurrent adult brain tumor
  • adult brain stem glioma
  • adult medulloblastoma
  • adult glioblastoma
  • childhood high-grade cerebral astrocytoma
  • adult anaplastic astrocytoma
  • childhood choroid plexus tumor
  • childhood grade III meningioma
  • adult anaplastic ependymoma
  • adult mixed glioma
  • adult central nervous system germ cell tumor
  • adult ependymoblastoma
  • recurrent childhood brain stem glioma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood cerebral astrocytoma
  • recurrent childhood medulloblastoma
  • adult choroid plexus tumor
  • recurrent childhood ependymoma
  • adult grade III meningioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201