Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I/II Study of Topotecan (SKF 104864) With Recombinant GM-CSF (Sargramostim) Used as a Priming Agent in Advanced Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Colony-stimulating factors such as sargramostim may increase the
number of immune cells found in bone marrow or peripheral blood and may help a person's
immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of topotecan plus sargramostim in
treating patients who have advanced cancer.
OBJECTIVES: I. Identify a priming schedule of sargramostim (GM-CSF) that reduces the
percentage of progenitor cells in cycle at the time of chemotherapy administration in
patients with advanced malignancies. II. Determine the maximum tolerated dose and toxic
effects of topotecan when administered with sargramostim in these patients. III. Conduct a
preliminary assessment of the activity of this topotecan regimen in these patients.
OUTLINE: This is a dose escalation study of topotecan. Patients receive priming with
sargramostim (GM-CSF) on days -4 through -2. On day 0, topotecan IV is administered over 30
minutes. Cohorts of 6 patients receive escalating doses of topotecan. The maximum tolerated
dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience
dose-limiting toxicity (DLT). Sargramostim resumes on day 1 following topotecan, and
continues for 5 days or until sufficient hematologic recovery. The next course of topotecan
is given 48 hours later. Treatment repeats every 6 weeks for 4 courses. Patients are followed
every 3 months for the first year, then every 6 months thereafter.
PROJECTED ACCRUAL: 15-25 patients will be accrued for the duration of 18 months.
;
| 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 |
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 |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| 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 |
NCT00255658 -
Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00126620 -
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |