Alvocidib in Treating Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• 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 alvocidib in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Alvocidib may also stimulate the immune system in different ways and stop tumor cells from growing. It may also stop the growth of solid tumors by blocking blood flow to the tumor.

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

Details

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

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor

• Locally advanced or metastatic disease for which curative treatment does not exist or is no longer effective

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

• No previously irradiated* measurable lesion unless lesion demonstrates progressive disease OR there are other measurable lesions outside the irradiated* field

• The following are not considered measurable disease:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural or pericardial effusion

• Lymphangitis cutis/pulmonis

• Abdominal masses that are not confirmed and followed by imaging techniques

• Cystic lesions

• No uncontrolled brain metastases

• Performance status - ECOG 0-1

• At least 6 months

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Bilirubin ≤ 1.5 times ULN

• Creatinine ≤ 1.5 times ULN

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No uncontrolled cardiac arrhythmia

• No uncontrolled hypertension

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol

• No ongoing or active infection

• No uncontrolled illness

• No psychiatric illness or social situation that would preclude study compliance

• More than 12 weeks since prior hepatic arterial chemoembolization

• More than 4 weeks since prior systemic chemotherapy

• No prior flavopiridol

• See Disease Characteristics

• More than 12 weeks since prior radioactive metaiodobenzylguanidine (MIBG)

• More than 4 weeks since prior external beam radiotherapy

• Recovered from all prior tumor-specific therapy

• More than 4 weeks since prior investigational tumor-specific therapy

• Concurrent octreotide for control of carcinoid syndrome allowed

• No concurrent combination anti-retroviral therapy for HIV-positive patients

• No other concurrent tumor-specific therapy

• No other concurrent investigational therapy

• No other concurrent anticancer therapy