CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Head and Neck Cancer, Lymphoma

Thank you

Trial Information

CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor


OBJECTIVES:

- Determine the response rate in patients with central nervous system malignancies
treated with intensive chemotherapy supported by autologous peripheral blood stem cell
transplantation following surgical resection and/or radiotherapy.

- Determine the disease-free survival and overall survival of this patient population
treated with these regimens.

- Determine the toxicity of this high-dose chemotherapy regimen in these patients.

- Assess the quality of life of these patients following these treatment regimens.

OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or
primary neuroectodermal tumor undergo initial surgical resection followed by conventional or
stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also
receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and
cisplatin prior to high-dose chemotherapy.

All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose
chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3,
carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3.
Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered
concurrently with stem cell harvesting and transplantation.

Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy
at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose
chemotherapy.

Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of
life is assessed at follow-up.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant tumors

- Anaplastic astrocytoma

- Oligodendroglioma

- Germ cell tumor

- Medulloblastoma

- Primary neuroectodermal tumor

- Esthesioneuroblastoma

- CNS lymphoma (primary or systemic disease)

- Multifocal intracranial disease allowed

- No extraneural metastases (except controlled systemic lymphoma)

- Pretreatment considerations based on tumor type

- Anaplastic astrocytoma:

- Recurrent disease

- Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)

- Chemotherapy not required at recurrence

- Oligodendroglioma:

- Disease response (at least minor) to conventional chemotherapy OR

- Recurrent disease

- Esthesioneuroblastoma:

- Attempted complete surgical resection

- Disease progression after radiotherapy

- Response to chemotherapy regimen comprising cyclophosphamide, etoposide,
and cisplatin

- CNS lymphoma:

- Disease refractory to methotrexate OR

- Failure after initial treatment with methotrexate OR

- Considered at high risk for disease relapse despite initial response

- Radiographic or pathological confirmation of recurrent disease required

- Not eligible for other high priority national or institutional clinical studies

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG or Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Creatinine less than 1.5 times normal

Cardiovascular:

- LVEF at least 45%

Pulmonary:

- DLCO at least 60% predicted OR

- Approval of pulmonologist

Other:

- Not pregnant or nursing

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent anticancer hormonal therapy

- No concurrent steroids as antiemetics

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

Other:

- No concurrent barbiturates or acetaminophen

- Participation in other concurrent supportive care or gene therapy trials allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Charles S. Hesdorffer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068360

NCT ID:

NCT00007982

Start Date:

April 1999

Completion Date:

May 2008

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Head and Neck Cancer
  • Lymphoma
  • recurrent adult brain tumor
  • adult medulloblastoma
  • adult oligodendroglioma
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • adult anaplastic astrocytoma
  • adult central nervous system germ cell tumor
  • primary central nervous system non-Hodgkin lymphoma
  • adult anaplastic oligodendroglioma
  • Head and Neck Neoplasms
  • Lymphoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032