Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS

NCT00520468 | Completed Phase 2 Results

• 1 other identifier: 2004-0253
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk myelodysplastic syndromes (MDS). Secondary: To evaluate response duration, survival and side effects of the treatment.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; MDS; Erythropoietin; Darbepoetin alfa; Aranesp; Erythropoiesis stimulating protein; G-CSF; Filgrastim; Neupogen; Prednisone; Cyclosporin A; Sandimmune; CYA; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response

  Periodic bone marrow samples (every 3-6 months) to check cells related to disease before/during/after study. Response classifications categorized by the International Working Group Response Criteria for Myelodysplastic Syndrome (MDS) as: Complete Remission, Partial Response, Hematologic Improvement or No Response.

  Response evaluation within first 3 months from start of therapy, then every 3 to 6 months

Study Arms (1)

Cytokine-Immunotherapy

EXPERIMENTAL

Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice a week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily

Drug: Erythropoietin; Drug: Cyclosporin A; Drug: G-CSF; Drug: Prednisone

Interventions

Erythropoietin DRUG

40,000 units injected under the skin (SQ) weekly

Also known as: Darbepoetin alfa, Aranesp, Erythropoiesis stimulating protein

Cytokine-Immunotherapy

Cyclosporin A DRUG

300 mg (tablets) by mouth daily for 6 months

Also known as: CYA, Cyclosporine, Sandimmune

Cytokine-Immunotherapy

G-CSF DRUG

300 mcg injected under the skin (SQ) two times per week

Also known as: Filgrastim, Neupogen

Cytokine-Immunotherapy

Prednisone DRUG

60 mg per day for 7 days, taper over 1 month

Cytokine-Immunotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with MDS and \</= 10% blasts or International Prognostic Scoring System (IPSS) low or intermediate 1. No prior intensive chemotherapy or high-dose ara-C (\>/= 1g/m2). Prior cytokines, biologic therapies, targeted therapies, or single agent chemotherapy allowed. Procrit, G-CSF are allowed before therapy. Patients with blasts \< 5% must have an indication for therapy, such as transfusion needs, symptomatic anemia or Hb \< 11g/dl, platelets \< 100 x 10 9/L, or granulocytes \< 10 9/L.
• Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate liver function (bilirubin of \< 2mg/dl) and renal function (creatinine \< 2mg/dl). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded)
• Signed informed consent

You may not qualify if:

• Nursing and pregnant females are excluded. Women of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Patients with active and uncontrolled infections.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M.D. Anderson Cancer Center's Website

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Erythropoietin; Darbepoetin alfa; Cyclosporine; Granulocyte Colony-Stimulating Factor; Filgrastim; Prednisone

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Gautam Borthakur, MBBS / Assistant Professor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-792-7305

Study Officials

• Gautam Borthakur, MBBS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 24, 2007
• Study Start: June 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 7, 2012
• Results First Posted: April 14, 2011

Record last verified: 2012-08

Locations

US (1)