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This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mantle Cell Lymphoma | Experimental | Patients with relapsed or refractory mantle cell lymphoma |
|
| Diffuse Large B Cell Lymphoma | Experimental | Patients with relapsed or refractory diffuse large B cell lymphoma |
|
| Multiple Myeloma | Experimental | Patients with relapsed or refractory multiple myeloma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canfosfamide HCl for injection | Drug | 30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 6 weeks of treatment |
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 12 weeks of treatment |
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 18 weeks of treatment |
| Objective Response Rate | Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity. | At 24 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Duration of response will be determined after disease progression is documented in patients who have an objective response. | At 6, 12, 18 & 24 weeks of treatment |
| Safety Assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Bertino, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| D016393 | Lymphoma, B-Cell |
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C107479 | TER 286 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.
| At 3, 6, 9, & 12 weeks of treatment |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |