Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003194
First received: April 6, 2000
Last updated: February 6, 2009
Last verified: March 2003
  Purpose

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: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.


Condition Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: thiotepa
Drug: topotecan hydrochloride
Procedure: peripheral blood stem cell transplantation
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Thiotepa in Combination With Carboplatin and Topotecan With Peripheral Blood Progenitor Cell Support for the Treatment of Children With Recurrent or Refractory Solid Tumors.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 24
Study Start Date: July 1997
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose escalation study of thiotepa.

Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection.

Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients receive 3 courses of therapy.

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

Patients are followed at 1 and 2 years.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued into this study.

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven recurrent or refractory pediatric solid tumor
  • Bone marrow metastases allowed

PATIENT CHARACTERISTICS:

Age:

  • 1 to 30

Performance status:

  • 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 100,000/mm3 (transfusion independent)
  • Hemoglobin at least 10 g/dL (RBC transfusion allowed)

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 2.5 times normal

Renal:

  • Adequate renal function as defined by one of the following:

    • GFR by creatinine clearance
    • Radioisotope GFR
    • Iothalamate at least 70 mL/min

Cardiovascular:

  • Adequate cardiac function as defined by one of the following:

    • Ejection fraction at least 55% by MUGA
    • Fractional shortening at least 28% by echocardiogram

Neurologic:

  • Adequate CNS function as defined by:

    • Seizure disorder, if present, controlled by anticonvulsants
    • CNS toxicity no greater than grade 2

Other:

  • No uncontrolled infections
  • Not pregnant or nursing
  • No allergy to platinum compounds
  • No history of allergy to etoposide (unless mobilization phase not required)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Recovered from prior immunotherapy
  • At least 1 week since prior cytokines
  • At least 3 months since prior bone marrow or peripheral blood stem cell transplantation
  • No concurrent immunomodulator
  • No concurrent cytokines

Chemotherapy:

  • At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered
  • No prior thiotepa
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Recovered from prior radiotherapy
  • At least 6 months since prior total body irradiation conditioning
  • No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow

Surgery:

  • Not specified
  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: NCT00003194

Locations
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Study Chair: Douglas Hawkins, MD Seattle Children's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003194     History of Changes
Other Study ID Numbers: CDR0000066029, CHMC-6006, FHCRC-1244.00, NCI-G98-1373
Study First Received: April 6, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Carboplatin
Cyclophosphamide
Thiotepa
Topotecan
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014