Tocladesine in Treating Patients With Recurrent or Refractory Multiple Myeloma

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

tocladesine

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004902

First Posted

March 7, 2000

Last Updated

May 17, 2012

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00004902

Brief Title

Tocladesine in Treating Patients With Recurrent or Refractory Multiple Myeloma

Official Title

Phase II Pilot Evaluation of Infusional 8 Cl-cAMP in the Treatment of Relapsed or Refractory Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 1998 (undefined)

Primary Completion Date

November 1999 (Actual)

Study Completion Date

November 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

OBJECTIVES: I. Determine the safety of 8-chloro-cyclic adenosine monophosphate (8-chloro-cAMP) in patients with recurrent or refractory multiple myeloma. II. Evaluate the efficacy of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. OUTLINE: Patients receive 8-chloro-cyclic adenosine monophosphate (8-chloro-cAMP) over 120 hours every 2 weeks for up to 4 courses. Beginning with course 5, patients with stable or responsive disease receive 8-chloro-cAMP over 120 hours every 3 weeks until disease progression. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study within 12-18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

tocladesine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann Traynor, MD

Organizational Affiliation

Robert H. Lurie Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Multiple Myeloma and Plasma Cell Neoplasm

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial