Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Thalidomide vs. Placebo for Steroid Dependent or Refractory Chronic Graft vs. Host Disease (cGVHD) IND #42782
RATIONALE: Thalidomide may interfere with the body's ability to recognize transplanted bone
marrow cells as foreign and may help treat patients with graft-versus-host disease.
PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating
patients who have chronic graft-versus-host disease following bone marrow transplantation.
OBJECTIVES: I. Determine the efficacy of thalidomide in patients with steroid dependent or
refractory chronic graft vs host disease following an allogeneic bone marrow transplant. II.
Determine the toxicity of this regimen in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to the type of bone
marrow transplant received (allogeneic vs matched unrelated donor) and type of chronic graft
vs host disease (steroid dependent vs steroid refractory). Patients receive either oral
thalidomide or placebo 2-4 times a day for 6 months. The drug is then tapered until stopped.
If disease recurs, the drug may be restarted for a second 6 month course. The maximum
duration of treatment is 18 months. Patients continue on steroid therapy, which is tapered
during study therapy. If no response is seen after 8 weeks, patients may cross over to the
other alternate drug. Patients are followed weekly for 1 month, then every month for 1 year.
PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study.
;
Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00255658 -
Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors
|
Phase 1 |