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Childhood Burkitt LymphomaPhase 1NCT00101270

Oxaliplatin and Irinotecan in Treating Young Patients With Refractory Solid Tumors or Lymphomas

A Phase 1 study testing irinotecan hydrochloride and oxaliplatin in people with Childhood Burkitt Lymphoma and Childhood Central Nervous System Germ Cell Tumor, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of oxaliplatin when given together with irinotecan in treating young patients with refractory solid tumors or lymphomas. Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
irinotecan hydrochloride and oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Mar 2005to Sep 2007
Phase
Phase 1
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 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologically confirmed refractory malignant solid tumor or lymphoma
  • Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification
  • No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
  • Measurable or evaluable disease
  • Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following:
  • Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan
Show all 71Show fewer
  • Metastatic bone marrow disease
  • Elevated tumor markers
  • Presence of a malignant pleural effusion
  • No leukemia
  • Performance status - Karnofsky 50-100% (for patients > 10 years of age)
  • Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
  • Not specified
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 5 times ULN
  • Albumin ≥ 2 g/dL
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
  • Creatinine based on age as follows:
  • No greater than 0.8 mg/dL (for patients age 5 and under)
  • No greater than 1.0 mg/dL (for patients age 6 to 10)
  • No greater than 1.2 mg/dL (for patients age 11 to 15)
  • No greater than 1.5 mg/dL (for patients age 16 and over)
  • No arrhythmia on EKG
  • No evidence of dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry > 94% on room air and no evidence of pulmonary fibrosis by chest radiograph* or CT scan
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Weight ≥ 10 kg
  • Neurologic deficits relatively stable for ≥ 1 week before study entry (patients with CNS tumors only)
  • No electrolyte (e.g., sodium, potassium, bicarbonate, calcium, magnesium, and phosphate) abnormality ≥ grade 2 (electrolyte supplementation allowed)
  • No uncontrolled infection
  • No history of life-threatening allergy to camptothecin derivatives or platinum agents
  • No sensory or motor peripheral neuropathy ≥ grade 2
  • No elevation of amylase or lipase ≥ grade 2
  • Able to tolerate enteral medications (e.g., cefixime, cefpodoxime, or loperamide)
  • Recovered from all prior immunotherapy
  • At least 7 days since prior hematopoietic growth factors
  • At least 7 days since prior antineoplastic biologic therapy
  • Prior stem cell transplantation or rescue without total-body irradiation (TBI) allowed provided ≥ 3 months have elapsed and there is no evidence of active graft-versus-host disease
  • No concurrent immunotherapy
  • No concurrent biologic therapy
  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
  • No prior oxaliplatin
  • No other concurrent chemotherapy
  • Concurrent steroids allowed provided dose has been stable for ≥ 7 days before study entry
  • See Biologic therapy
  • Recovered from all prior radiotherapy
  • At least 2 weeks since prior local palliative small port radiotherapy
  • At least 6 months since prior TBI
  • At least 6 months since prior craniospinal, whole spinal, or whole lung/abdominal 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
  • No concurrent radiotherapy
  • No other concurrent investigational drugs
  • No other concurrent anticancer therapy
  • No concurrent cephalosporin antibiotics
  • No concurrent use of any of the following:
  • Phenytoin
  • Carbamazepine
  • Oxcarbazepine
  • Barbiturates
  • Rifampin
  • Phenobarbital
  • Azole antifungal agents
  • Aprepitant
  • Hypericum perforatum (St. John's wort)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • COG Phase I Consortium

    Arcadia, California, 91006-3776

Other trials in United States

About this study

Official title: A Phase I Study of Oxaliplatin (NSC# 266046, IND #57004) and Irinotecan in Pediatric Patients With Refractory Solid Tumors and Lymphomas

This phase I trial is studying the side effects and best dose of oxaliplatin when given together with irinotecan in treating young patients with refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may help irinotecan kill more cancer cells by making cancer cells more sensitive to the drug. Giving oxaliplatin together with irinotecan may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose of oxaliplatin when administered with irinotecan in pediatric patients with refractory solid tumors or lymphomas.

II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients.

SECONDARY OBJECTIVES:

  1. Determine, preliminarily, the antitumor activity of this regimen in these patients.

II. Correlate UGT and BCRP genotype with the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of oxaliplatin.

Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Medical subject headings
Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Astrocytoma, Familial ependymoma, Dendritic Cell Sarcoma, Interdigitating, Medulloblastoma, Optic Nerve Glioma, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00101270
Study groupRoleWhat they receive
Treatment (irinotecan hydrochloride, oxaliplatin)ExperimentalPatients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: irinotecan hydrochloride; Drug: oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT

    Graded using the NCI CTCAE version 3.0.

    Measured: 21 days

Secondary outcomes (1)

  1. Overall response assessed using RECIST criteria

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionSep 2007

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101270
Sponsor's protocol ID
NCI-2012-01819
Other IDs
ADVL0415, CDR0000401518, COG-ADVL0415, U01CA097452
Status last verified
Jun 2013
First submitted
7 Jan 2005
Last updated
5 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing irinotecan hydrochloride and oxaliplatin in people with Childhood Burkitt Lymphoma and Childhood Central Nervous System 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 71 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101270.

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.

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