Ovarian Cancer Clinical Trial
Official title:
Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
with bone marrow transplantation or peripheral stem cell transplantation works in treating
patients with relapsed germ cell cancer.
OBJECTIVES:
- Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens
with autologous stem cell rescue in patients with relapsed germ cell cancer.
- Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem
cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support
in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem
cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells
cannot be collected.
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel
IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and
carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a
second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours,
then CBDCA and ifosfamide on days -6 to -4.
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV
is given twice a day until 3 consecutive postnadir days of granulocytes of at least
1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again
administered.
Surgery may be performed after course 2 if indicated.
PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
| Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
| Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
| Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
| Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |