17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00079404
• Date of registration: 08/03/2004
• Primary sponsor: Children's Oncology Group
• Public title: 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
• Scientific title: A Phase I Study of 17-AAG in Relapsed/Refractory Pediatric Patients With Solid Tumors or Leukemia
• Date of first enrolment: March 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00079404
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

Canada, United States

Contacts

• Name: Brenda Weigel, MD
• Affiliation: Masonic Cancer Center, University of Minnesota

• Name: Joseph P. Neglia, MD, MPH
• Affiliation: Masonic Cancer Center, University of Minnesota

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of solid tumor or leukemia with documented M3
marrow

- Histologic confirmation of intrinsic brain stem tumors not required

- Relapsed or refractory disease

- No known curative therapy

- In patients with CNS tumors, neurologic deficits must be stable for at least the past
week

PATIENT CHARACTERISTICS:

Age

- 1 to 21

Performance status

- Karnofsky 50-100% (>10 years of age)

- Lansky 50-100% (= 10 years of age)

Life expectancy

- Not specified

Hematopoietic

- For patients with solid tumors:

- Absolute neutrophil count = 1,000/mm^3

- Platelet count = 100,000/mm^3 (transfusion independent)

- Hemoglobin = 8.0 g/dL (may receive RBC transfusions)

- For patients with leukemia:

- Platelet count = 20,000/mm^3 (may receive platelet transfusions)

- Hemoglobin = 8.0 g/dL (may receive RBC transfusions)

Hepatic

- Bilirubin = 1.5 times upper limit of normal (ULN)

- ALT = 2.5 times ULN

- Albumin = 2 g/dL

Renal

- Creatinine clearance OR radioisotope glomerular filtration rate = 70 mL/min OR

- Creatinine based on age as follows:

- = 0.8 mg/dL if = 5 years of age

- = 1.0 mg/dL if > 5 years and = 10 years of age

- = 1.2 mg/dL if > 10 years and = 15 years of age

- = 1.5 mg/dL if > 15 years and = 21 years of age

Other

- No uncontrolled infection

- No prior severe allergy to eggs

- No situation that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 7 days (or window for adverse effects has passed) since prior biologic
therapy and recovered

- At least 7 days since prior hematopoietic growth factors

- At least 2 months since prior stem cell transplantation and no evidence of
graft-vs-host disease

- No concurrent hematopoietic growth factors

- No concurrent biologic therapy

- No concurrent immunotherapy

Chemotherapy

- At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
and recovered

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent steroid therapy

Radiotherapy

- At least 2 weeks since prior local palliative radiotherapy (small port)

- At least 3 months since prior total body irradiation or craniospinal radiotherapy

- At least 3 months since prior radiotherapy to = 50% of the pelvis

- At least 6 weeks since prior substantial bone marrow radiotherapy

- Recovered from prior radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- No other concurrent investigational drugs

- No other concurrent anticancer agents

- No concurrent phenytoin or phenobarbital

- No concurrent warfarin



Age minimum: 1 Year
Age maximum: 21 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Leukemia

Unspecified Childhood Solid Tumor, Protocol Specific

Intervention(s)

Drug: tanespimycin

Secondary ID(s)

CDR0000355714

COG-ADVL0316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)