NCT00070239

Brief Summary

This phase I trial is studying the side effects and best dose of alvocidib in treating patients with metastatic or unresectable refractory solid tumors or hematologic malignancies. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop cancer cells from dividing so they stop growing or die.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

October 3, 2003

Last Update Submit

December 13, 2013

Conditions

Hematopoietic/Lymphoid CancerUnspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT)

    28 days

  • MTD (or recommended phase II dose), defined as one dose level below that which produces two instances of DLT during the first 28-day course and the level at which no more than one of six patients experiences DLT during course 1

    28 days

Secondary Outcomes (3)

  • Pharmacokinetic parameters, including maximum concentration (Cmax), half-life, area under the curve (AUC), clearance, and volume of distribution

    24 hours, 48 hours, 72 hours, and 8 weeks

  • Potency of alvocidib in plasma based on change in proliferation of stimulated peripheral blood mononuclear cells (PBMCs)

    Baseline to up to 72 hours of day 1 course 1

  • Change in tumor metabolism and proliferation assessed by fludeoxyglucose F 18 (FDG) and fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET)

    Baseline to up to day 19 of course 2

Study Arms (1)

Treatment

EXPERIMENTAL

PART 1 (closed to accrual as of 8/2005): Patients receive alvocidib IV over 1 hour on days 1, 8, and 15. Cohorts of 3-6 patients receive escalating doses of alvocidib until the MTD\* is determined. PART 2: Patients receive alvocidib IV over 1 hour at or below the MTD determined in part 1 and then receive a maintenance dose of alvocidib IV over 1-6 hours on days 1, 8, and 15. Cohorts of 3-6 patients receive escalating durations of the maintenance dose of alvocidib until the MTD\* is determined. An additional cohort of 10-20 patients receives alvocidib over 1 hour on days 1 and 15 at the MTD. NOTE: \*The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. In both parts, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: alvocidibOther: pharmacological studyRadiation: fludeoxyglucose F 18Other: fluorine F 18 fluorothymidineProcedure: positron emission tomography

Interventions

alvocidibDRUG

Given IV

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Treatment
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment
fludeoxyglucose F 18RADIATION

Correlative studies

Also known as: 18FDG, FDG
Treatment
fluorine F 18 fluorothymidineOTHER

Correlative studies

Also known as: 18F-FLT, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F-18
Treatment
positron emission tomographyPROCEDURE

Correlative studies

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignancy, including the following types:
  • Hematologic malignancy, including any of the following: (Accrual for patients with hematologic malignancies temporarily closed as of 11/30/04)
  • Mantle cell lymphoma
  • Morphologically confirmed disease
  • CD20 and CD5 positive
  • Any other refractory lymphoma
  • Chronic lymphocytic leukemia
  • Rai stage III or IV and meeting at least 1 of the following criteria for active disease:
  • Weight loss \> 10% in the last 6 months
  • Fatigue
  • Fever or night sweats with no evidence of infection
  • Progressive anemia or thrombocytopenia
  • Progressive lymphocytosis with a lymphocyte doubling time of \< 6 months
  • Marked hypogammaglobulinemia or paraproteinemia
  • Progressive splenomegaly and/or lymphadenopathy
  • +81 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

alvocidibFluorodeoxyglucose F18alovudineMagnetic Resonance Spectroscopy2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Geoffrey Shapiro

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

August 1, 2003

Primary Completion

June 1, 2006

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

US(1)