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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00101 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000433593 | |||
| 2004-0792 | Other Identifier | M D Anderson Cancer Center | |
| 6936 | Other Identifier | CTEP | |
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| R21CA117070 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well 17-AAG works in treating patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVE:
I. Determine the complete and partial response rates and time to treatment failure in patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).
SECONDARY OBJECTIVES:
I. Determine the safety of this drug in these patients. II. Determine the biologic effect of this drug on selected molecular targets in primary lymphoma cells from these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (anaplastic large cell lymphoma vs mantle cell lymphoma vs Hodgkin's lymphoma).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response.
After completion of study treatment, patients are followed every 3 months until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response. After completion of study treatment, patients are followed every 3 months until disease progression. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tanespimycin | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Response | Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses. | Baseline to time to best response; Every 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anas Younes | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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Recruitment Period: 02/08/2005 through 05/08/2009. All participant recruitment attempted at UT MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 17-AAG | 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 17-AAG | 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Patients With Response | Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses. | Analysis was intention to treat (ITT). All participants with baseline and at least one post baseline target lesion measurement were included. | Posted | Number | participants | Baseline to time to best response; Every 6 weeks |
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4 years and 1 month
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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 | 17-AAG | 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days | 3 | 22 | 21 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Blurred Vision | Eye disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypertension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypotension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anas Younes, MD / Professor | UT MD Anderson Cancer Center | etubbs@mdanderson.org |
| ID | Term |
|---|---|
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D006689 | Hodgkin Disease |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
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| ID | Term |
|---|---|
| C112765 | tanespimycin |
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