Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma

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

Summary

This phase I trial is studying the side effects and best dose of ispinesib in treating young patients with relapsed or refractory solid tumors or lymphoma. Drugs used in chemotherapy, such as ispinesib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Histologically confirmed malignancy at either original diagnosis or relapse, including the following:

• Solid tumor, including primary CNS tumors

• Neurologic deficits in patients with CNS tumors must have been relatively stable for ≥ 1 week

• Patients with CNS tumors must be on stable or decreasing doses of dexamethasone for the past 7 days

• Histology requirement waived for intrinsic brain stem tumors

• Lymphoma

• Measurable or evaluable disease

• No known curative therapy or no therapy proven to prolong survival with an acceptable quality of life exists

• Patients with known bone marrow metastases are eligible for study but are not evaluable for hematologic toxicity

• Not known to be refractory to red blood cell or platelet transfusions

• Karnofsky performance score (PS) 60-100% (> 10 years of age) or Lansky PS 60-100% (≤ 10 years of age)

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to study enrollment)

• Hemoglobin ≥ 8.0 g/dL (RBC transfusions allowed)

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows:

• No greater than 0.8 mg/dL (≤ 5 years of age)

• No greater than 1.0 mg/dL (6 to 10 years of age)

• No greater than 1.2 mg/dL (11 to 15 years of age)

• No greater than 1.5 mg/dL (> 15 years of age)

• Bilirubin ≤ 1.5 times upper limit of normal

• ALT ≤ 45 U/L

• Albumin ≥ 2 g/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No evidence of active graft-vs-host disease

• No uncontrolled infection

• Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy

• More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)

• More than 1 week since prior growth factors, including those that support platelet or WBC number or function

• At least 1 week since prior biologic agents

• At least 2 weeks since prior local, palliative, small-port external-beam radiotherapy

• At least 6 months since prior total body irradiation (TBI), craniospinal radiotherapy, or radiotherapy to ≥ 50%of the pelvis

• At least 6 weeks since other prior substantial bone marrow radiotherapy (i.e., skull, spine, pelvis, or ribs)

• At least 3 months since prior stem cell transplantation or rescue without TBI

• No other concurrent investigational drugs

• No other concurrent anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy

• No concurrent enzyme-inducing anticonvulsants, including any of the following:

• Phenytoin

• Phenobarbital

• Felbamate

• Primdone

• Oxcarbazepine

• Carbamazepine

• No concurrent agents that inhibit CYP3A4, including any of the following:

• Itraconazole

• Ketoconazole

• Voriconazole