Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma
Part of paid clinical trials in Houston, Texas.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT00458731
- Phase
- PHASE1
- Status
- Completed
Conditions
- Adult Grade III Lymphomatoid Granulomatosis
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Childhood Burkitt Lymphoma
- Childhood Diffuse Large Cell Lymphoma
- Childhood Grade III Lymphomatoid Granulomatosis
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Noncutaneous Extranodal Lymphoma
- Peripheral T-cell Lymphoma
- Progressive Hairy Cell Leukemia, Initial Treatment
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Hairy Cell Leukemia
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Stage IV Adult Burkitt Lymphoma
- Stage IV Adult Diffuse Large Cell Lymphoma
- Stage IV Adult Diffuse Mixed Cell Lymphoma
- Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
- Stage IV Adult Hodgkin Lymphoma
- Stage IV Adult Immunoblastic Large Cell Lymphoma
- Stage IV Adult Lymphoblastic Lymphoma
- Stage IV Adult T-cell Leukemia/Lymphoma
- Stage IV Childhood Anaplastic Large Cell Lymphoma
- Stage IV Childhood Hodgkin Lymphoma
- Stage IV Childhood Large Cell Lymphoma
- Stage IV Childhood Lymphoblastic Lymphoma
- Stage IV Childhood Small Noncleaved Cell Lymphoma
- Stage IV Grade 1 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Stage IV Mantle Cell Lymphoma
- Stage IVA Mycosis Fungoides/Sezary Syndrome
- Stage IVB Mycosis Fungoides/Sezary Syndrome
- T-cell Large Granular Lymphocyte Leukemia
- Testicular Lymphoma
- Unspecified Adult Solid Tumor, Protocol Specific
- Unspecified Childhood Solid Tumor, Protocol Specific
- Waldenström Macroglobulinemia
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICALGiven IV
- cediranib maleate — DRUGGiven orally
Study Details
This phase I trial is studying the side effects and best dose of bevacizumab and cediranib maleate in treating patients with metastatic or unresectable solid tumor, lymphoma, intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Cediranib maleate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bevacizumab and cediranib maleate may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving bevacizumab together with cediranib maleate may kill more cancer cells.
Key Dates
- First listed
- Apr 11, 2007
- Start date
- May 31, 2007
- Status verified
- Dec 2013
- Primary completion
- Dec 31, 2013
Study Design
- Enrollment
- 57 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (cediranib maleate and bevacizumab)Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral cediranib maleate once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bevacizumab and cediranib maleate until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Primary Outcome Measure
Safety and toxicity profile of combination bevacizumab and cediranib maleate [ Time Frame: Up to 6 weeks post-treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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