Isotretinoin Plus Dexamethasone in Treating Patients With Multiple Myeloma

July 9, 2013 updated by: Fox Chase Cancer Center

A Phase II Trial of Dexamethasone and 13-cis-Retinoic Acid as First-Line Treatment for Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with dexamethasone may be an effective treatment for multiple myeloma.

PURPOSE: Phase II trial to study the effectiveness of combining isotretinoin and dexamethasone in treating patients who have multiple myeloma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the response rate and duration of response of patients with multiple myeloma treated with dexamethasone and isotretinoin. II. Determine the toxicity of this regimen in these patients. III. Correlate the changes in serum interleukin (IL)-6, IL-6R, and C-reactive and IL-6R expression on plasma cells in the bone marrow with response in patients treated with this regimen.

OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20 and oral isotretinoin daily. Treatment repeats every 5 weeks for at least 2 courses in the absence of disease progression, insufficient response, or unacceptable toxicity. Patients achieving adequate response continue treatment for 2 courses after achieving a plateau of monoclonal protein, for a minimum of 6 courses total.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Regional Cancer Center
      • Lakewood, New Jersey, United States, 08701
        • Kimball Medical Center
      • Millville, New Jersey, United States, 08332
        • South Jersey Regional Cancer Center
      • Mount Holly, New Jersey, United States, 08060
        • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center - Booker Cancer Center
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
      • Trenton, New Jersey, United States, 08629
        • St. Francis Medical Center
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Bon Secours-Holy Family Health System
      • Drexel Hill, Pennsylvania, United States, 19026
        • Delaware County Memorial Hospital
      • Harrisburg, Pennsylvania, United States, 17105-8700
        • Pinnacle Health Hospitals
      • Johnstown, Pennsylvania, United States, 15905
        • Conemaugh Memorial Hospital
      • Langhorne, Pennsylvania, United States, 19047
        • Saint Mary Regional Center
      • Lansdale, Pennsylvania, United States, 19446-1200
        • North Penn Hospital
      • Paoli, Pennsylvania, United States, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Memorial Regional Cancer Center
      • Reading, Pennsylvania, United States, 19612-6052
        • Reading Hospital and Medical Center
      • West Grove, Pennsylvania, United States, 19390
        • Southern Chester County Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Elevated monoclonal protein in serum and/or urine

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3* Platelet count at least 75,000/mm3* *Unless secondary to multiple myeloma involvement of the bone marrow Hepatic: Bilirubin less than 1.5 mg/dL Transaminase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL No overt renal insufficiency Cardiovascular: No congestive heart failure No myocardial infarction within the past 6 months No significant arrhythmia or poorly controlled hypertension Pulmonary: No severe pulmonary disease Other: Triglycerides normal No other severe medical illness No active peptic ulcer disease No brittle insulin-dependent diabetes No severe depression or other psychiatric illness No active infection No history of severe ethanol or drug abuse Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior palliative radiotherapy allowed Surgery: At least 3 weeks since prior major surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

July 1, 2000

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

March 10, 2004

First Posted (Estimate)

March 11, 2004

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068772
  • FCCC-95043 (Other Identifier: Fox Chase Cancer Center)
  • NCI-G01-1985 (Other Grant/Funding Number: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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