Lymphoma Clinical Trial
Official title:
Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
Verified date | September 2017 |
Source | The Methodist Hospital System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan
works in treating patients with primary CNS lymphoma.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria DISEASE CHARACTERISTICS: - Histologically confirmed primary CNS lymphoma at initial diagnosis - Measurable tumor by radiography - Failed* OR is not a candidate for first-line high-dose systemic methotrexate-based chemotherapy with or without radiotherapy NOTE: *Failure is defined as relapse, progression, or failure to achieve a complete response PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 50-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count = 1,500/mm^3 - Platelet count = 100,000/mm^3 - Hemoglobin = 9 g/dL Hepatic - SGOT and SGPT = 3 times upper limit of normal - Bilirubin = 2.0 mg/dL Renal - Creatinine clearance > 40 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No known allergy to temozolomide or topotecan - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission - No other major medical illness or psychiatric impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic growth factors Chemotherapy - See Disease Characteristics - At least 6 weeks since prior nitrosoureas - At least 2 weeks since prior methotrexate Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - Not specified Other - Recovered from all prior therapy - At least 4 weeks since prior non-nitrosourea cytotoxic drugs (except methotrexate) - At least 4 weeks since prior systemic investigational agents - At least 2 weeks since prior non-cytotoxic antitumor drugs - No other concurrent antitumor therapy EXCLUSION CRITERA 1. Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception. 2. Known allergy to temozolomide or topotecan. 3. Severe vomiting or other inability to administer medications orally. 4. Major medical illnesses or psychiatric impairment that in the investigator's opinion will prevent administration or completion of the protocol therapy and/or will interfere with follow-up. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Methodist Hospital System | Baylor College of Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of complete radiologic response (CR) | July 2006 | ||
Secondary | Median overall survival | July 2006 | ||
Secondary | Failure-free survival | July 2006 | ||
Secondary | Toxicity | July 2006 | ||
Secondary | Overall response rate (CR and partial response) | July 2006 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT04270266 -
Mind-Body Medicine for the Improvement of Quality of Life in Adolescents and Young Adults Coping With Lymphoma
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Completed |
NCT01949883 -
A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma
|
Phase 1 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Recruiting |
NCT05019976 -
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
|
N/A | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Completed |
NCT04434937 -
Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
|
Phase 2 | |
Completed |
NCT01855750 -
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
|
Phase 3 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Terminated |
NCT00775268 -
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03936465 -
Study of the Bromodomain (BRD) and Extra-Terminal Domain (BET) Inhibitors BMS-986158 and BMS-986378 in Pediatric Cancer
|
Phase 1 |