Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase II Study of Intrathecal Topotecan (NSC #609699) in Patients With Refractory Meningeal Malignancies
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well topotecan hydrochloride works in treating children with meningeal cancer that has not responded to previous treatment
PRIMARY OBJECTIVES:
I. Determine the therapeutic activity of intrathecal topotecan, in terms of response rate
and time to central nervous system (CNS) progression, in pediatric patients with recurrent
or refractory neoplastic meningitis.
II. Determine the safety and toxicity of this regimen in these patients. III. Evaluate the
concentration of matrix metalloproteinases (MMPs) in the cerebrospinal fluid (CSF) of these
patients.
OUTLINE: Patients are stratified according to disease type (acute lymphoblastic leukemia vs.
other leukemia/lymphoma vs medulloblastoma vs other solid tumors). (Recurrent CNS acute
lymphoblastic leukemia stratum only open to accrual as of 11/30/04)
INDUCTION: Patients receive topotecan hydrochloride intrathecally (IT) over 5 minutes twice
weekly for 6 weeks.
CONSOLIDATION: Beginning 1 week after completion of induction, patients receive topotecan
hydrochloride IT over 5 minutes weekly for 4 weeks in the absence of disease progression or
unacceptable toxicity.
MAINTENANCE: Beginning 2 weeks after completion of consolidation, patients receive topotecan
hydrochloride IT over 5 minutes twice monthly for 4 months and then monthly through year 1.
After completion of study treatment, patients are followed up monthly for 3 months, every 3
months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-77 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01164163 -
INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease
|
Phase 1 | |
| Completed |
NCT00985868 -
AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors
|
Phase 1 | |
| Terminated |
NCT00949117 -
Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
|
Phase 2 | |
| Completed |
NCT00281944 -
Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT00253474 -
PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
|
Phase 1 | |
| Recruiting |
NCT00084695 -
Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases
|
Phase 2 | |
| Completed |
NCT00053963 -
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
|
Phase 1 | |
| Completed |
NCT00003070 -
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
|
Phase 3 | |
| Completed |
NCT00004212 -
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00016861 -
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
|
Phase 1 | |
| Completed |
NCT00004005 -
Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
|
Phase 2 | |
| Completed |
NCT00003754 -
Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers
|
Phase 2 | |
| Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT00898794 -
Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer
|
N/A | |
| Terminated |
NCT00429702 -
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy
|
Phase 2 | |
| Completed |
NCT00387920 -
Sunitinib in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT00459238 -
Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
|
N/A | |
| Completed |
NCT00138216 -
Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
| Terminated |
NCT00176540 -
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
|
N/A |