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Anti-Thymocyte Globulin and Etanercept in Treating Patients With Myelodysplastic Syndromes

Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases

Intervention: anti-thymocyte globulin (Biological); etanercept (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
Bart L. Scott, MD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center

Summary

RATIONALE: Biological therapies, such as anti-thymocyte globulin and etanercept, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-thymocyte globulin together with etanercept may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with etanercept works in treating patients with myelodysplastic syndromes.

Clinical Details

Official title: Therapy of Early Stage Myelodysplastic Syndrome (MDS) With ATG and Etanercept

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Response rate

Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic, and functional disease characteristics with in vivo treatment responses

Identify parameters that are associated with a high probability of response

Detailed description: OBJECTIVES:

- Determine the response rate in patients with low- or intermediate-1-risk

myelodysplastic syndromes treated with anti-thymocyte globulin and etanercept.

- Correlate ex vivo and in vitro phenotypic, cytogenetic, and functional disease

characteristics with in vivo response in patients treated with this regimen.

- Determine parameters that are associated with a high probability of response or

non-response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive anti-thymocyte globulin IV over 8 hours on days 1-4. Patients also receive etanercept subcutaneously on days 8, 11, 15, and 18. Treatment with etanercept repeats every 28 days for at least 2 courses. Patients exhibiting hematologic improvement after course 2 may receive up to 2 additional courses of etanercept in the absence of disease progression or unacceptable toxicity. Patients with unresponsive disease or disease progression after course 2 are removed from the study and offered other treatment. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of myelodysplastic syndromes (MDS)

- Low- or intermediate-1-risk disease, as defined by International Prognostic

Scoring System (IPSS) criteria, meeting 1 of the following criteria:

- Single or multilineage cytopenia, as defined by all of the following:

- Absolute neutrophil count < 1,500/mm^3

- Hemoglobin < 10 g/dL

- Platelet count < 100,000/mm^3

- Transfusion requirement of ≥ 2 units of packed red blood cells within an

8-week period

- Not eligible for stem cell transplantation due to any of the following reasons:

- No suitable bone marrow donor available

- Not eligible for a transplantation protocol

- Not willing to undergo transplantation

- No intermediate-2- or high-risk MDS

- No chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS: Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Not specified

Renal

- Not specified

Pulmonary

- No pneumonia within the past 2 weeks

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other severe disease that would preclude study compliance

- No other active severe infection (e. g., septicemia) within the past 2 weeks

PRIOR CONCURRENT THERAPY: Biologic therapy

- More than 4 weeks since prior and no concurrent hematopoietic growth factors for MDS

- More than 4 weeks since prior immunomodulatory therapy for MDS

- No prior anti-thymocyte globulin

- No prior hematopoietic stem cell transplantation

- No other concurrent immunomodulatory therapy for MDS

Chemotherapy

- Not specified

Endocrine therapy

- Prednisone < 5 mg/day allowed

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 4 weeks since prior and no concurrent cytotoxic therapy for MDS

- More than 4 weeks since prior experimental therapy for MDS

- No other concurrent experimental therapy for MDS

Locations and Contacts

St. Joseph Cancer Center, Bellingham, Washington 98225-1898, United States

Olympic Medical Center, Port Angeles, Washington 98362, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States

Seattle Cancer Care Alliance, Seattle, Washington 98109-1023, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2004
Last updated: September 13, 2010

Page last updated: August 20, 2015

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