Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003754
First received: November 1, 1999
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

RATIONALE: Thalidomide may kill tumor cells by stopping the growth of new blood vessels to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and cyclophosphamide in treating children who have recurrent or refractory childhood cancers.


Condition Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: cyclophosphamide
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Thalidomide and Cyclophosphamide in Patients With Recurrent or Refractory Malignancies

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: September 1998
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies.

OUTLINE: Patients receive oral thalidomide 4 times daily. Cyclophosphamide is administered IV over 1 hour once every 4 weeks, beginning on the same day as thalidomide. Treatment continues in the absence of unacceptable toxicity or disease progression. Tumor response is assessed every 3 months.

PROJECTED ACCRUAL: A total of 45-80 patients will be accrued for this study within 2 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven pediatric malignancy, except when there is appearance consistent with brainstem tumor on MRI, a tumor marker positive for germ cell tumor, or ophthalmologic diagnosis of intraocular retinoblastoma Failed conventional treatment or conventional therapy is not available Measurable disease by MRI, CT scan, biochemical tumor markers, cytology, or bone marrow examination

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Lansky 60-100% OR Karnofsky 60-100% Life expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 750/mm3 (between 300-750/mm3, if due to bone marrow infiltration by malignancy) Platelet count at least 75,000/mm3 (between 20,000-75,000/mm3, if due to bone marrow infiltration by malignancy) Hepatic: Bilirubin less than 2.0 mg/dL ALT less than 3 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN OR Creatinine clearance at least 70 mL/min Neurologic: No peripheral neuropathy grade 3 or 4 No seizure disorder in patients without CNS malignancies Other: Not pregnant or nursing Negative pregnancy tests during study and for 1 month after final dose of thalidomide Fertile patients must use effective contraception during and for at least 1 month after study

PRIOR CONCURRENT THERAPY: See Disease Characteristics No limit on the number of prior agents or regimens received Biologic therapy: Prior bone marrow transplantation allowed Chemotherapy: Recovered from prior chemotherapy No prior thalidomide Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 4 weeks since prior major surgery (2 weeks for minor surgery, excluding central venous catheter placement procedures)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003754

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Ira Dunkel, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003754     History of Changes
Other Study ID Numbers: 98-088, CDR0000066878, MSKCC-98088A(4), NCI-G99-1498
Study First Received: November 1, 1999
Last Updated: June 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Cyclophosphamide
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014