Tocladesine in Treating Patients With Recurrent or Refractory Multiple Myeloma

This study has been completed.

First Received: March 7, 2000 Last Updated: November 16, 2008 History of Changes

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004902

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: tocladesine	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: 8-Chloro-cyclic adenosine monophosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Pilot Evaluation of Infusional 8 Cl-cAMP in the Treatment of Relapsed or Refractory Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 1999

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004902

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Ann Traynor, MD

Robert H. Lurie Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067581, NU-97H4, NCI-G00-1681
Study First Received:	March 7, 2000
Last Updated:	November 16, 2008
ClinicalTrials.gov Identifier:	NCT00004902 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
8-chloro-cyclic adenosine monophosphate
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Recurrence
Multiple Myeloma
Hemorrhagic Disorders
Lymphoproliferative Disorders
Adenosine
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
8-chloro-cyclic adenosine monophosphate
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009