NCT00002652

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients who have refractory or relapsed multiple myeloma or Castleman's disease.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 1995

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1995

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 1, 2004

Completed
Last Updated

February 4, 2013

Status Verified

April 1, 2002

First QC Date

November 1, 1999

Last Update Submit

February 1, 2013

Conditions

Keywords

refractory multiple myeloma

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Confirmed diagnosis of active multiple myeloma Refractory (less than a partial response) to or relapsed after standard chemotherapy Myeloma protein present for response evaluation Nonsecretory myeloma eligible if plasmacytosis greater than 30% OR Pathologic diagnosis of Castleman's disease Multicentric or symptomatic disease requiring therapy Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 1 year Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT no greater than 2 times upper limit of normal PT and PTT normal No coagulopathy Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Calcium no greater than 12 mg/dL Other: No severe psychiatric disorder that would preclude informed consent No known seizure disorder No peripheral neuropathy or POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome No uncontrolled or brittle diabetes mellitus HIV negative No other active medical illness that would preclude study No other malignancy within the past 5 years except nonmelanomatous skin cancer or stage IA cervical carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks since prior mitomycin or nitrosoureas) Endocrine therapy: At least 4 weeks since prior glucocorticoids (e.g., prednisone, dexamethasone) Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to more than 20% of bone marrow Surgery: At least 4 weeks since prior surgery Other: Recovered from the toxic effects of prior therapy No other concurrent 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)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Suramin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic Compounds

Study Officials

  • Nikhil C. Munshi, MD

    University of Arkansas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 1, 2004

Study Start

May 1, 1995

Study Completion

February 1, 2004

Last Updated

February 4, 2013

Record last verified: 2002-04

Locations