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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib

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