Extragonadal Germ Cell TumorPhase 2NCT00002489
Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors
A Phase 2 study testing dactinomycin, filgrastim and carboplatin in people with Extragonadal Germ Cell Tumor and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Extragonadal Germ Cell Tumor, Ovarian Cancer
- What is being tested?
- dactinomycin, filgrastim and carboplatin
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1991to Jun 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Malignant germ cell tumors of the following stages and primary sites: Stage II/III/IV ovarian tumors Grade II/III immature glial teratomas Stage II/III/IV mediastinal tumors Stage II/III/IV presacral tumors and tumors of other primary sites No intracranial or testicular primary sites
PATIENT CHARACTERISTICS: Age: Child Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
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.
Read the detailed description
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.
- Conditions
- Extragonadal Germ Cell Tumor, Ovarian Cancer
- Being tested
- dactinomycin, filgrastim, carboplatin, cyclophosphamide, doxorubicin hydrochloride
- Keywords
- stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian teratoma, extragonadal germ cell tumor
- Medical subject headings
- Ovarian Neoplasms, Teratoma, Ovarian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dactinomycinBiological
filgrastimBiological
carboplatinDrug
cyclophosphamideDrug
etoposideDrug
methotrexateDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2004 (estimated)
- Study startOct 1991
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extragonadal Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Norma Wollner, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002489
- Sponsor's protocol ID
- 91-119
- Other IDs
- CDR0000077384, NCI-V92-0021
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS
- ClinicalTrials.gov ID
- NCT00002489
- Acronym / sponsor ID
- 91-119
- Conditions
- Extragonadal Germ Cell Tumor, Ovarian Cancer
- Keywords
- stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian teratoma, extragonadal germ cell tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 1991
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 30 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dactinomycin | Biological | – |
| filgrastim | Biological | – |
| carboplatin | Drug | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| leucovorin calcium | Drug | – |
| methotrexate | Drug | – |
| vincristine sulfate | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
Related trials for Extragonadal Germ Cell Tumor
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
Active, not recruitingPhase 3
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Germ Cell Tumor, Teratoma
RecruitingPhase 2
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Germ Cell Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norma Wollner, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dactinomycin, filgrastim and carboplatin in people with Extragonadal Germ Cell Tumor and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.