Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
This study has been terminated.
(Slow accrual.)
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00070291
First received: October 3, 2003
Last updated: February 12, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: cyclosporine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by Eastern Cooperative Oncology Group:
Primary Outcome Measures:
- Response Rate (Complete and Partial Response) [ Time Frame: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up. ] [ Designated as safety issue: No ]Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year. ] [ Designated as safety issue: No ]Overall survival was defined as time from randomization to death from any cause.
| Enrollment: | 4 |
| Study Start Date: | September 2005 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cyclosporine
High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
|
Drug: cyclosporine
Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
Other Names:
|
Detailed Description:
OBJECTIVES:
Primary
- Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.
Secondary
- Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
- At least one objective measurable or evaluable disease parameter.
- Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
- Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal.
- Total bilirubin <= 2x the upper limit of normal.
- Age 18 or older.
Exclusion Criteria:
- Prior cyclosporine or Tacrolimus (FK506).
- Prior allogeneic transplant.
- Evidence of active infection.
- Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
- Evidence of active neurological impairment.
- Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
- History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
- pregnant or breastfeeding women.
- Human immunodeficiency virus (HIV) positive.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070291
Locations
| United States, California | |
| Stanford Cancer Center | |
| Stanford, California, United States, 94305-5824 | |
| United States, Illinois | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60504 | |
| Hematology Oncology Associates of Illinois - Berwyn | |
| Berwyn, Illinois, United States, 60402 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Hematology and Oncology Associates | |
| Chicago, Illinois, United States, 60611 | |
| Saint Joseph Hospital | |
| Chicago, Illinois, United States, 60657 | |
| Midwest Center for Hematology/Oncology | |
| Joliet, Illinois, United States, 60432 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | |
| Libertyville, Illinois, United States, 60048 | |
| La Grange Oncology Associates - Geneva | |
| Naperville, Illinois, United States, 60563 | |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | |
| Niles, Illinois, United States, 60714 | |
| Hematology Oncology Associates - Skokie | |
| Skokie, Illinois, United States, 60076 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Iowa | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49001 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Ohio | |
| St. Rita's Medical Center | |
| Lima, Ohio, United States, 45801 | |
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
| Study Chair: | Ranjana Advani, MD | Stanford University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00070291 History of Changes |
| Other Study ID Numbers: | CDR0000331864, U10CA021115, E2402 |
| Study First Received: | October 3, 2003 |
| Results First Received: | January 7, 2013 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eastern Cooperative Oncology Group:
|
angioimmunoblastic T-cell lymphoma |
Additional relevant MeSH terms:
|
Immunoblastic Lymphadenopathy Lymphoma Lymphoma, T-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Histologic Type Neoplasms Lymphoma, Non-Hodgkin Cyclosporins Cyclosporine |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013