Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors

Ovarian Cancer Clinical Trial

Official title:

A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005952
• Other study ID #: 1735
• Secondary ID: DUMC-1735-04-9R5
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 5, 2000
• Last updated: June 19, 2013
• Start date: August 2000
• Est. completion date: November 2005

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentDuke University Health System Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors.

• Evaluate the toxicity of this treatment in these patients.

• Determine the activity of this treatment in these patients.

OUTLINE: This is a dose escalation study of temozolomide.

Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for 1-3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR

• Histologically confirmed non-CNS tumor

• Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma)

• Recurrent or resistant neuroblastoma

• Recurrent Wilm's tumor

• Recurrent Ewing's sarcoma

• Recurrent primitive neuroectodermal tumors

• Recurrent nasopharyngeal carcinoma

• Recurrent germ cell tumor

• Expected cure rate less than 10% with standard therapy

• Measurable and/or active disease

• History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and under

Performance status:

• Karnofsky 70-100% OR

• Lansky 70-100%

Life expectancy:

• Greater than 8 weeks

Hematopoietic:

• Reasonably cellular bone marrow (greater than 15% cellularity on biopsy)

• Absolute neutrophil count greater than 1,000/mm^3

• Platelet count greater than 75,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

• SGPT less than 120 U/L

Renal:

• Creatinine less than 1.5 mg/dL

Cardiovascular:

• Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram

Pulmonary:

• CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No active infection

• Able to tolerate vigorous hydration schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent white blood cell transfusion

• No other concurrent hematopoietic growth factors

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy

• No other concurrent cytotoxic drugs (systemic or intrathecal)

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics

• At least 1 week since prior radiotherapy

Surgery:

• At least 1 week since prior surgery

Other:

• No other concurrent investigational agents

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Childhood Germ Cell Tumor
• Head and Neck Cancer
• Head and Neck Neoplasms
• Kidney Cancer
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Nervous System Neoplasms
• Neuroblastoma
• Ovarian Cancer
• Sarcoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• temozolomide

Procedure:
• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response at 12 months			No
Primary	Disease-free survival at 12 months			No
Secondary	Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months			Yes
Secondary	Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months			No