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A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma


Phase 1
5 Years
18 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma


OBJECTIVES:

- Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric
patients with progressive or recurrent glioblastoma multiforme or anaplastic
astrocytoma.

- Determine the safety of this drug in these patients.

- Determine the efficacy of this drug in these patients.

- Compare the efficacy of this drug in patients with different histological types of
tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody
titer levels.

OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to
1 of 2 treatment groups by age (5-9 vs 10-18).

All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2
intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107).

- Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter.
Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three
cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum
tolerated dose (MTD) is determined.

- Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two
cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is
determined.

The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

Patients are followed monthly for 6 months and then every 3 months for 6 months.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed glioblastoma multiforme or anaplastic astrocytoma with the
following tumor characteristics:

- Unifocal

- Unilateral and supratentorial

- Diameter no greater than 3.5 cm by contrast-enhanced MRI

- No more than 1 satellite tumor

- Recurrent or progressive disease

- Progressive disease defined as at least 25% increase in tumor volume by serial
MRI or CT scans and/or at least 15% increase in the largest cross-sectional area
of tumor as defined by the area of contrast agent enhancement

- Must have received prior conventional treatment comprising both of the following:

- Surgery (biopsy or debulking)

- Radiation therapy

- No evidence of mass effect on CT scan or MRI with more than a 5 mm midline shift
and/or nausea, vomiting, reduced level of consciousness, or clinically significant
papilledema

PATIENT CHARACTERISTICS:

Age

- 5 to 18

Performance status

- Karnofsky 60-100% OR

- Lansky Play 50-100%

Life expectancy

- At least 3 months

Hematopoietic

- Platelet count at least 100,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- AST and ALT no greater than 2.5 times the upper limit of normal (ULN)

- PT or aPTT no greater than 1.5 times ULN

Renal

- Not specified

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 2 months
after study

- No acute viral, bacterial, or fungal infection requiring therapy

- Topical treatment for oral candidiasis allowed

- No other concurrent medical condition that would preclude anesthesia

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior transferrin-CRM107

Chemotherapy

- More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- More than 3 months since prior biodegradable polymer wafers

- No concurrent chemotherapy

Endocrine therapy

- Must be on stable dose of steroids for 7 days prior to infusion

Radiotherapy

- See Disease Characteristics

- More than 3 months since prior radiotherapy

- More than 3 months since prior stereotactic radiosurgery

- More than 6 weeks since prior craniospinal irradiation

- No prior brachytherapy

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- More than 1 month since prior surgery including tumor surgery or debulking

- No other concurrent surgery

Other

- More than 30 days since prior investigational agents

- No other concurrent investigational therapy

- No other concurrent anti-cancer drugs

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Patrick Rossi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Xenova Biomedix

Authority:

United States: Federal Government

Study ID:

CDR0000258574

NCT ID:

NCT00052624

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent childhood cerebral astrocytoma
  • Astrocytoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Children's Hospital of Orange CountyOrange, California  92668
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425