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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| E2402 | Other Identifier | Eastern Cooperative Oncology Group (ECOG) |
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Slow accrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (Complete and Partial Response) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as time from randomization to death from any cause. | Assessed every 3 months for 2 years, then every 6 months for 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ranjana Advani, MD | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94305-5824 | United States | ||
| Rush-Copley Cancer Care Center |
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Participants were recruited from ECOG member institutions between September 2, 2005 and March 24, 2009. The first patient was accrued on January 24, 2006. The study was terminated due to slow accrual.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step 1 |
|
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|
|
| Aurora |
| Illinois |
| 60504 |
| United States |
| Hematology Oncology Associates of Illinois - Berwyn | Berwyn | Illinois | 60402 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Hematology and Oncology Associates | Chicago | Illinois | 60611 | United States |
| Saint Joseph Hospital | Chicago | Illinois | 60657 | United States |
| Midwest Center for Hematology/Oncology | Joliet | Illinois | 60432 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | 60048 | United States |
| La Grange Oncology Associates - Geneva | Naperville | Illinois | 60563 | United States |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois | 60714 | United States |
| Hematology Oncology Associates - Skokie | Skokie | Illinois | 60076 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
| Step 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclosporine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Response Rate (Complete and Partial Response) | 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. | all 4 enrolled patients | Posted | Number | 95% Confidence Interval | Proportion of participants | 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. |
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| |||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as time from randomization to death from any cause. | all 4 enrolled patients | Posted | Median | 95% Confidence Interval | Months | Assessed every 3 months for 2 years, then every 6 months for 1 year. |
|
|
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematologic-other | Blood and lymphatic system disorders | CTCAE3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia (Leukocytes, decreased) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia (Neutrophils, decreased) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia (Platelets, decreased) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hematologic-other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ gr3-4 neut, urinary tract | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine, increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-other | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-limb, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072281 | Lymphadenopathy |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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