Return to List

Study Summary
No. 2007-0615:.......Advanced Cancers; Bone; Brain; CNS; Eye; Kidney; Melanoma; Oropharynx; Ovary; Pediatrics; Phase I Studies; Sarcoma; Solid Tumors; Testis......Dennis P. Hughes......Pediatrics
.
Study Summary Title
Study Summary
Number:
2007-0615
Study Title:A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Panitumumab in Children with Solid Tumors
.
Physician New Patient Referral
Name:Dennis P. HughesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6620
Contact us about clinical trials
.
General Information
Disease Group:Advanced Cancers
Bone
Brain
CNS
Eye
Kidney
Melanoma
Oropharynx
Ovary
Pediatrics
Phase I Studies
Sarcoma
Solid Tumors
Testis
Supported By:Amgen, Inc.
Phase of Study:Phase IReturn
Visit:
Cohorts A or D: Weekly; Cohort B: q 2 weeks; Cohort C: q 3 weeks. All cohorts:
4 weeks after last treatment or more often if clinically necessary.
Treatment
Agents:
PanitumumabHome Care:None.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find the highest tolerable dose
of panitumumab that can be given to children with solid tumors whose tumors
have come back or did not go away after earlier treatment(s).
.
Study Objectives / Outcomes
Primary
The primary objective of this study is to evaluate the safety and pharmacokinetics (PK)
of up to 3 different dose schedules of panitumumab in pediatric subjects with solid
tumors.

Secondary
The secondary objectives are to evaluate the incidence of human anti-panitumumab
antibody (HAPA) formation and to determine preliminarily if there is evidence of
anti-tumor activity of panitumumab in this patient population.

Exploratory
The exploratory objectives are to investigate potential biomarkers based on assessment
of blood cells, tumor cells, the proposed mechanism of action of panitumumab, the effect
of genetic variation in cancer genes, and drug target genes on subject response to
panitumumab.
.
Study Status Information
Study Activation / Registration Date:12/19/2007
IRB Review and Approval Date:12/19/2007
Study Type:Phase I
Recruitment Status:Open
Projected Accrual:36
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Histologically or cytologically confirmed solid tumor that has recurred after standard therapy, or for which there is no standard therapy. Subjects with brainstem glioma DO NOT need histologic proof of the diagnosis.

2) Central nervous system (CNS) tumors (primary or metastatic) are allowed. Note: Subjects who have received prior radiotherapy for CNS metastases must have a minimum of 4 weeks elapsed since last dose of radiotherapy and be considered medically stable and must be on a stable dose of corticosteroids for a minimum of 2 weeks prior to participation in the study.

3) Paraffin-embedded tumor tissue from primary tumor or metastasis for determination of EGFr expression and biomarker testing (not required for brainstem gliomas, if not available)

4) Presence of measurable or non-measurable disease

5) Life expectancy of >/= 12 weeks

6) Performance status: Karnofsky >/= 60% for 12 to < 18 years of age; Lansky play scale >/= 60% for children 1 to < 12 years of age

7) 1 to < 18 years of age

8) Adequate hematologic function: Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L; platelet count >/= 75 x 10^9/L; hemoglobin >/= 9 g/dL.

9) Adequate renal function: Serum creatinine </= 1.5 x upper limit of normal (ULN) for age

10) Adequate hepatic function: Aspartate aminotransferase (AST) </= 3 x ULN (</= 5 X ULN if liver metastases); alanine aminotransferase (ALT) </= 3 x ULN (</= 5 X ULN if liver metastases); total bilirubin </= 1.5 X ULN; magnesium >/= lower limit of normal.

11) Adequate pulmonary function: Resting oxygen saturation on room air >/= 92% by pulse oximetry.

12) Medications: All previous therapy-related toxicities must have resolved or returned to baseline

13) Ethical: All parents or legal guardians must provide voluntary, signed-written informed consent before any study-specific procedure is conducted. In addition to providing written informed consent, the assent of the child (if applicable) must also be obtained in accordance with the institutional review board/independent ethics committee before any study-specific procedure is conducted.

Exclusion Criteria:1) Diagnosis of leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, or other hematologic malignancy

2) Any prior allogeneic transplant

3) Prior autologous bone marrow or peripheral stem cell transplant less than 3 months prior to study enrollment

4) Substantial radiotherapy to the bone marrow within 6 weeks prior to enrollment (or within 6 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 59% of the pelvis was received; within 2 weeks prior to enrollment if local palliative radiotherapy was received)

5) Prior use of any monoclonal antibodies targeting the EGFr. Subjects who have received prior tyrosine kinase inhibitors such as gefitinib (IressaŽ) or erlotinib (TarcevaŽ) are eligible.

6) Immunotherapy, radiotherapy, or chemotherapy </= 2 weeks prior to enrollment (</= 6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin, and </= 6 weeks from prior antibody therapy)

7) Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy (except for pain control), or any other investigational drug while on this study

8) Prior seizures < 3 months prior to enrollment. Subjects with a history of seizure disorders >/= 3 months prior to enrollment must be seizure free and on stable anticonvulsant medication(s) for >/= 3 months prior to enrollment.

9) Presence of a serious uncontrolled medical disorder

10) Dementia, altered mental status, or any other medical condition or disorder that would prohibit the understanding or rendering of assent (if applicable), or ability to comply with study procedures

11) Major surgery </= 28 days prior to enrollment

12) Known or suspected history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)

13) Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >/= CTC grade 2 [CTCAE version 3.0])

14) Known positive test for human immunodeficiency virus infection, hepatitis C virus infection, acute or chronic hepatitis B infection, or any co-morbid disease that would increase risk of toxicity

15) Females of childbearing potential not using adequate contraception precautions for the duration of the study treatment and for 2 months after the last administration of investigational product

16) Pregnant or breast-feeding, or planning to become pregnant during study treatment and within 2 months after the last administration of investigational product

17) Received investigational therapy or procedure </= 30 days prior to enrollment

.
Links
Registration Number: NCT00658658
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
.
Results


Return to Clinical Trials at M.D. Anderson Cancer Center