Kidney Cancer Clinical Trial

Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas

Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.

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Full Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas.

II. Determine the toxic effects and pharmacokinetics of this drug in these patients.

III. Determine the antitumor activity of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

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

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 18 months.

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Eligibility Criteria

Inclusion Criteria:

Histologically confirmed relapsed or refractory solid tumor or lymphoma including:

Neuroblastoma
Osteosarcoma
Ewing's sarcoma
Rhabdomyosarcoma
Wilms tumor
CNS tumors
Histological verification not required for brainstem tumors
No acute leukemia
Not eligible for higher priority COG phase I/II study
Performance status - Karnofsky 50-100% (over age 10)
Performance status - Lansky 50-100% (age 10 and under)
At least 2 months
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 75,000/mm^3 (transfusion independent)
Hemoglobin at least 8.0 g/dL (transfusion allowed)
No granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow involvement
Bilirubin no greater than 1.5 times normal
SGPT no greater than 5 times normal
Albumin at least 2 g/dL
Creatinine no greater than 1.5 times normal
Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal
Shortening fraction at least 27% by echocardiogram
Ejection fraction at least 50% by MUGA
Stable neurologic deficits within the past 2 weeks for patients with CNS tumors
CNS toxicity less than grade 2
No active graft-versus-host disease
No active uncontrolled infection or other serious medical condition
No uncontrolled diabetes mellitus
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
At least 7 days since prior biologic therapy and recovered
Prior bone marrow or stem cell transplantation allowed
At least 6 months since prior allogeneic stem cell transplantation
At least 1 week since prior growth factors
No concurrent immunomodulating agents
At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
No other concurrent chemotherapy
Concurrent dexamethasone for CNS tumors allowed if on stable dose for at least 2 weeks prior to study
Concurrent corticosteroids allowed only for increased intracranial pressure in patients with CNS tumors
At least 2 weeks since prior local (small port) palliative radiotherapy
At least 6 months since prior radiotherapy to 50% or more of the pelvis
At least 6 months since prior craniospinal radiotherapy
At least 6 weeks since other prior substantial bone marrow radiotherapy
Recovered from prior radiotherapy
No concurrent radiotherapy except localized palliative radiotherapy
No concurrent anticonvulsants

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT00012181

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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COG Phase I Consortium
Arcadia California, 91006, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT00012181

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

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