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NephroblastomaPhase 2NCT00001509

A Phase II Trial of All-Trans-Retinoic Acid in Combination With Interferon-Alpha 2a in Children With Recurrent Neuroblastoma or Wilms' Tumor

A Phase 2 study testing IFN-alpha with retinoic acid in people with Nephroblastoma and Neuroblastoma, 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

A body of preclinical data has provided a strong rationale for evaluating the combination of IFN-alpha with retinoic acid. The two drugs have different mechanisms of action and, when used in combination, show enhanced activity in both adult and pediatric tumor cell lines. Read more about this study

Who is it for?
Any age
Conditions the study is for
Nephroblastoma, Neuroblastoma
What is being tested?
IFN-alpha with retinoic acid
How many people
60 participants
Where
1 siteUnited States
Study dates
Jul 1996to May 2000
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

AGE:

All patients must be less than or equal to 21 years of age.

PERFORMANCE STATUS:

Patients should have an ECOG performance status of 0, 1, or 2, and a life expectancy of at least 8 weeks.

HISTOLOGIC DIAGNOSIS:

Patients with the following diagnosis, confirmed by appropriate histologic examination, will be eligible for this study: neuroblastoma and Wilms' tumor.

MEASURABLE DISEASE:

Patients must have measurable disease. Patients with evaluable disease only (i.e., limited to positive bone scan or bone marrow) are eligible only if the bone involvement is measurable by alternative imaging modalities (MRI, CT, or plain film).

PROGRESSIVE DISEASE:

Patients must have evidence of progressive disease following or during prior therapy.

HEMATOLOGIC FUNCTION:

Patients do not have to be evaluable for hematologic toxicity to be enrolled onto the study. Patients without bone marrow involvement by tumor, with no history of BMT, and with no prior cranio-spinal or pelvic radiation, will be considered evaluable for hematologic toxicity.

Patients evaluable for hematologic toxicity must have adequate bone marrow function (defined as peripheral absolute granulocyte count of greater than 1500/mm(3), hemoglobin greater than 8.0 gm% and platelet count greater than 100,000/mm(3)).

HEPATIC FUNCTION:

Patients must have adequate liver function (bilirubin less than 2.0 mg%; SGPT less than 2 times normal).

RENAL FUNCTION:

Patients must have adequate renal function defined as a creatinine clearance greater than or equal to 70 ml/min/1.732 or a serum creatinine based on age as follows:

equal to or less than 5 years old: maximum serum creatinine 0.8;

older than 5 but equal to or less than 10: 1.0;

older than 10 but equal to or less than 15: 1.2;

older than 15: 1.5.

RECOVERY FROM PRIOR THERAPY:

Patients must have recovered from the toxic effects of prior therapy, and must be off of all chemotherapy for a minimum of two weeks prior to entry onto the protocol (a minimum of six weeks for prior nitrosoureas).

INFORMED CONSENT:

All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study.

No history of CNS malignant disease, hydro-cephalus, or pseudotumor cerebri.

No history of treatment with 13-cis retinoic acid within the prior three months.

Women of childbearing potential must not be pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Cancer Institute (NCI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

A body of preclinical data has provided a strong rationale for evaluating the combination of IFN-alpha with retinoic acid. The two drugs have different mechanisms of action and, when used in combination, show enhanced activity in both adult and pediatric tumor cell lines.

The combination of the antiproliferative and differentiation inducing effect of retinoids together with the antiproliferative, immunostimulatory and differentiation-potentiating effects of IFN-alpha warrant clinical investigation of this combination for the treatment of refractory pediatric malignancies.

Read the detailed description

A body of preclinical data has provided a strong rationale for evaluating the combination of IFN-alpha with retinoic acid. The two drugs have different mechanisms of action and, when used in combination, show enhanced activity in both adult and pediatric tumor cell lines. In the pediatric phase I trial which administered ATRA for 3 consecutive days/week repeated weekly, the AUC of ATRA decreased on day 1 to day 3 of drug administration but returned to day 1 levels at the beginning of subsequent weeks. This intermittent schedule of ATRA administration allowed for exposure to relatively high plasma concentrations of ATRA on a repetitive basis. The combination of ATRA/IFN-alpha 2a has demonstrated clinical activity in the pediatric phase I trial in neuroblastoma and Wilms' tumor. The combination of the antiproliferative and differentiation inducing effect of retinoids together with the antiproliferative, immunostimulatory and differentiation-potentiating effects of IFN-alpha warrant clinical investigation of this combination for the treatment of refractory pediatric malignancies.

Being tested
IFN-alpha with retinoic acid
Keywords
Differentiation, N-myc Expression, Retinoid, Solid Tumor, Trk Expression
Medical subject headings
Wilms Tumor, Neuroblastoma

What participants receive

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

  • IFN-alpha with retinoic acidDrug

Timeline

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

  1. First posted10 Dec 2002 (estimated)
  2. Study startJul 1996
  3. Study completionMay 2000

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 2
Primary purpose
Treatment
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001509
Sponsor's protocol ID
960117
Other IDs
96-C-0117
Status last verified
Jun 1999
First submitted
3 Nov 1999
Last updated
4 Mar 2008
Results posted
No

Publications

  • Smith MA, Adamson PC, Balis FM, Feusner J, Aronson L, Murphy RF, Horowitz ME, Reaman G, Hammond GD, Fenton RM, et al. Phase I and pharmacokinetic evaluation of all-trans-retinoic acid in pediatric patients with cancer. J Clin Oncol. 1992 Nov;10(11):1666-73. doi: 10.1200/JCO.1992.10.11.1666.

    PubMed 1403049

  • Smith MA, Parkinson DR, Cheson BD, Friedman MA. Retinoids in cancer therapy. J Clin Oncol. 1992 May;10(5):839-64. doi: 10.1200/JCO.1992.10.5.839.

    PubMed 1569455

  • Adamson PC, Bailey J, Pluda J, Poplack DG, Bauza S, Murphy RF, Yarchoan R, Balis FM. Pharmacokinetics of all-trans-retinoic acid administered on an intermittent schedule. J Clin Oncol. 1995 May;13(5):1238-41. doi: 10.1200/JCO.1995.13.5.1238.

    PubMed 7738627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IFN-alpha with retinoic acid in people with Nephroblastoma and Neuroblastoma, 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.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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?

On the ClinicalTrials.gov record for NCT00001509, which also lists 3 linked publications.

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 4 Mar 2008.

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