NCT00004902

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of tocladesine in treating patients who have recurrent or refractory multiple myeloma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1998

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
Last Updated

May 30, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

March 7, 2000

Last Update Submit

May 17, 2012

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

tocladesineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory multiple myeloma Measurable disease by monoclonal serum or urine globulins OR Malignant plasma cells documented on bilateral bone marrow biopsy Refractory after at least one prior therapeutic regimen (no more than 2 prior regimens allowed) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 60 mL/min Calcium no greater than 8.7 g/dL Cardiovascular: No history of arrhythmias No uncontrolled angina pectoris No symptomatic coronary ischemia No grade 3 or 4 congestive heart failure Cardiac ejection fraction greater than 35% by gated imaging Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior glucocorticoids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent theophylline therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

8-chloro-cyclic adenosine monophosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ann Traynor, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

July 26, 2004

Study Start

January 1, 1998

Primary Completion

November 1, 1999

Study Completion

November 1, 1999

Last Updated

May 30, 2012

Record last verified: 2012-05

Locations

US(1)