Clinical trial NCT00007982: Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer
Official title: CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Head and Neck Cancer
Lymphoma
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Response rate
measure: Disease-free suvival
measure: Overall survival
measure: Toxicity
measure: Quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
state: New York
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Charles S. Hesdorffer, MD
role: STUDY_CHAIR
References: