Childhood Central Nervous System Germ Cell TumorPhase 2NCT00091182
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
A Phase 2 study testing oxaliplatin in people with Childhood Central Nervous System Germ Cell Tumor and Childhood Extragonadal Germ Cell Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Childhood Central Nervous System Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Hepatoblastoma
- What is being tested?
- oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Feb 2006
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed* solid tumor, including any of the following:
- Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)
- Osteosarcoma
- Rhabdomyosarcoma
- Neuroblastoma
- High-grade astrocytoma
Show all 60Show fewer
- Low-grade astrocytoma
- Glioblastoma multiforme
- Ependymoma
- Hepatoblastoma
- Germ cell tumors of any site
- Rare tumors of interest, including any of the following:
- Soft tissue sarcoma
- Hepatocellular carcinoma
- Childhood/adolescent colorectal carcinoma
- Childhood/adolescent renal cell carcinoma
- Childhood/adolescent adrenocortical carcinoma
- Childhood/adolescent nasopharyngeal carcinoma
- Recurrent disease OR refractory to conventional therapy
- Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography
- Performance status - Karnofsky 50-100% (for patients over age 10)
- Performance status - Lansky 50-100% (for patients age 10 and under)
- At least 8 weeks
- Absolute neutrophil count ≥ 1,000/mm^3*
- Platelet count ≥ 75,000/mm^3* (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL* (RBC transfusions allowed)
- Granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow metastases or extensive prior radiotherapy allowed provided the above hematological criteria are met
- Bilirubin ≤ 3 mg/dL
- Creatinine based on age as follows:
- ≤ .8 mg/dL (for patients age 5 and under)
- ≤ 1.0 mg/dL (for patients age 6 to 10)
- ≤ 1.2 mg/dL (for patients age 11 to 15)
- ≤1.5 mg/dL (for patients age 16 to 21)
- Creatinine clearance or radioisotope glomerular filtration rate > 20 mL/min
- No uncontrolled seizure disorder
- No uncontrolled infection
- CNS toxicity ≤ grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Recovered from prior immunotherapy
- At least 7 days since prior anticancer biologic therapy
- More than 1 week since prior growth factors
- At least 6 months since prior allogeneic stem cell transplantation
- No evidence of active graft-vs-host disease
- No concurrent immunomodulating agents
- Recovered from prior chemotherapy
- No prior oxaliplatin
- Prior carboplatin or cisplatin allowed
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
- No other concurrent anticancer chemotherapy
- Concurrent dexamethasone for CNS tumors allowed provided patient has been on a stable or decreasing dose for ≥ 1 week before study entry
- Recovered from prior radiotherapy
- At least 2 weeks since prior local palliative radiotherapy (small port)
- At least 6 months since prior craniospinal radiotherapy
- At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial radiotherapy to the bone marrow
- Concurrent radiotherapy to localized painful lesions allowed provided ≥ 1 measurable lesion is not irradiated
- No other concurrent investigational agents
- No other concurrent anticancer agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Oncology Group
Arcadia, California, 91006-3776
About this study
Official title: A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
Read the detailed description
OBJECTIVES:
- Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.
II. Determine the cumulative toxicity of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. IV. Determine time to progression and overall survival of patients treated with this drug.
- Correlate the extent of oxaliplatin exposure with response in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
- Conditions
- Childhood Central Nervous System Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Hepatoblastoma, Childhood Hepatocellular Carcinoma, Childhood High-grade Cerebral Astrocytoma, Childhood Low-grade Cerebral Astrocytoma
- Being tested
- oxaliplatin
- Medical subject headings
- Hepatoblastoma, Astrocytoma, Ovarian Germ Cell Cancer, Testicular Neoplasms, Teratoma, Adrenocortical Carcinoma, Familial ependymoma, Optic Nerve Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startOct 2004
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Central Nervous System Germ Cell TumorStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Orren Beaty, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091182
- Sponsor's protocol ID
- NCI-2012-01815
- Other IDs
- ADVL0421, COG-ADVL0421, CDR0000384560, U10CA098543
- Status last verified
- Jun 2013
- First submitted
- 7 Sep 2004
- Last updated
- 5 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
- ClinicalTrials.gov ID
- NCT00091182
- Acronym / sponsor ID
- NCI-2012-01815
- Conditions
- Childhood Central Nervous System Germ Cell Tumor, Childhood Extragonadal Germ Cell Tumor, Childhood Hepatoblastoma, Childhood Hepatocellular Carcinoma, Childhood High-grade Cerebral Astrocytoma, Childhood Low-grade Cerebral Astrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 2004
- Primary completion
- Feb 2006 (actual)
- First posted
- 9 Sep 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.
This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES:
- Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.
II. Determine the cumulative toxicity of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. IV. Determine time to progression and overall survival of patients treated with this drug.
- Correlate the extent of oxaliplatin exposure with response in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: oxaliplatinPatients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (60 listed)
- Histologically confirmed* solid tumor, including any of the following:
- Recurrent disease OR refractory to conventional therapy
- Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography
- Performance status - Karnofsky 50-100% (for patients over age 10)
- Performance status - Lansky 50-100% (for patients age 10 and under)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV | Drug | Arm I |
Primary outcome
Response rate
Time frame: Up to 3 years
Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.
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 5 Jun 2013.
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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.
Orren Beaty principal investigator
Children's Oncology Group
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 oxaliplatin in people with Childhood Central Nervous System Germ Cell Tumor and Childhood Extragonadal Germ Cell Tumor, run by National Cancer Institute (NCI) 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?
The sponsor lists 60 inclusion and 0 exclusion criteria. 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 5 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.
What does the primary outcome measure?
Response rate (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
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 5 Jun 2013.