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DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas

Study Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of DX-8951f in treating children who have advanced solid tumors or lymphomas that have not responded to previous therapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed advanced solid tumors, including brain tumors and lymphomas, that have failed standard therapy (surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no standard therapy exists.
  • - Histology requirement waived for brain stem gliomas.
PATIENT CHARACTERISTICS: Age:
  • - 21 and under at diagnosis.
Performance status:
  • - ECOG 0-2.
Life expectancy:
  • - At least 8 weeks.
Hematopoietic:
  • - Absolute neutrophil count at least 750/mm^3.
  • - Platelet count at least 75,000/mm^3.
  • - Hemoglobin at least 8.5 g/dL.
Hepatic:
  • - Bilirubin no greater than 1.5 mg/dL.
  • - SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases) Renal: - Creatinine no greater than 1.5 times ULN OR.
  • - GFR at least 70 mL/min.
Other:
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - No history of severe or life-threatening hypersensitivity to camptothecin analogs.
  • - HIV negative.
  • - No other concurrent severe or uncontrolled medical illness.
  • - No systemic infection.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - Recovered from prior immunotherapy.
Chemotherapy:
  • - See Disease Characteristics.
  • - Recovered from prior chemotherapy.
Endocrine therapy:
  • - See Disease Characteristics.
Radiotherapy:
  • - See Disease Characteristics.
  • - At least 4 weeks since prior extensive radiotherapy involving cranial, whole pelvic, or at least 25% of bone marrow reserve.
  • - Recovered from prior radiotherapy.
  • - Concurrent localized radiotherapy for pain allowed.
Surgery:
  • - See Disease Characteristics.
  • - Recovered from prior surgery.
Other:
  • - No other concurrent antitumor therapy.
- No concurrent drugs that induce or inhibit CYP3A enzyme

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00004212
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Daiichi Sankyo
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Robert L. DeJager, MD, FACP
Principal Investigator Affiliation Daiichi Sankyo
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
Additional Details

OBJECTIVES:

  • - Determine the maximum tolerated dose of exatecan mesylate (DX-8951f) with and without filgrastim (G-CSF) in pediatric patients with advanced solid tumors or lymphomas.
  • - Determine the toxic effects, including dose-limiting toxicity, of exatecan mesylate in these patients.
  • - Determine the pharmacokinetics of exatecan mesylate in these patients.
  • - Determine the recommended dose of exatecan mesylate for phase II study.
  • - Determine the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of exatecan mesylate (DX-8951f). Patients are stratified according to prior treatment (minimally treated vs.#46;heavily treated). Patients receive exatecan mesylate IV over 30 minutes daily for 5 days. Patients in dose levels 5 and above also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing for at least 7 days or until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of exatecan mesylate with and without G-CSF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794

Children's Medical Center of Dallas, Dallas, Texas

Status

Address

Children's Medical Center of Dallas

Dallas, Texas, 75235

Institute for Drug Development, San Antonio, Texas

Status

Address

Institute for Drug Development

San Antonio, Texas, 78245-3217

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