Ovarian Cancer Clinical Trial
Official title:
PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
children who have non-testicular malignant germ cell tumors.
OBJECTIVES: I. Determine the efficacy of cyclophosphamide, carboplatin, and etoposide in
patients with non-testicular malignant germ cell tumors. II. Improve the quality of life of
these patients by shortening the length of treatment and the extent of initial surgical
resection. III. Determine whether histologic subtypes have prognostic significance. IV.
Determine the efficacy of short term chemotherapy in this patient population. V. Determine
the role of second look surgery in predicting curability of non testicular germ cell tumors.
VI. Determine the role of dose intensification of cyclophosphamide and the introduction of
doxorubicin, methotrexate, and dactinomycin for those patients with partial response, no
response, or progressive disease at the time of second look surgery.
OUTLINE: Patients undergo treatment on Regimen A consisting of surgical resection of tumor
as appropriate for disease followed by chemotherapy with cyclophosphamide IV over 20 minutes
on day 1, carboplatin IV on day 2, and etoposide IV on days 2-4. Patients receive filgrastim
(G-CSF) subcutaneously (SQ) daily beginning 24-48 hours following the last dose of etoposide
and continuing for 14 days or until blood counts recover (a total of 28 days). Chemotherapy
repeats every 3 weeks for 4 courses in the absence of disease progression. At week 11,
patients undergo second look surgery to evaluate response and resect any residual disease.
Patients with no residual disease receive no further therapy. Patients with good partial
response or no response receive salvage chemotherapy on Regimen B. Patients receive salvage
chemotherapy on Regimen B consisting of dactinomycin IV on days 1-3, doxorubicin IV and
vincristine IV continuously on days 1-3, and G-CSF SQ daily beginning 24-48 hours following
last dose of vincristine and continuing for 14 days or until blood counts recover. At week
3, patients receive cyclophosphamide IV on days 1-2, vincristine IV and doxorubicin IV
continuously on days 1-3 and G-CSF as previously given in Regimen B. At week 6, patients
receive methotrexate IV on day 1 and leucovorin calcium orally or IV every 6 hours for 3
days, beginning 16 hours after the completion of methotrexate. At week 8, salvage
chemotherapy repeats for an additional course. Patients achieving complete response
following salvage chemotherapy receive no further therapy. Patients with no response are
removed from study.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study over 6 years.
;
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 |