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Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver


OBJECTIVES:

- Determine the toxicity and maximum tolerated dose of intratumoral adenoviral
vector-delivered interleukin-12 gene in patients with liver metastases secondary to
colorectal cancer .

- Determine the tumor response in patients treated with this regimen.

- Determine the immune response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive ultrasound-guided intratumoral injections of adenoviral vector-delivered
interleukin-12 gene (ADV-hIL12) on day 1.

Cohorts of 3-6 patients receive escalating doses of ADV-hIL12 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.

Patients are followed at days 11, 15, 29, 43, and 57 and are then followed for survival
thereafter.

PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed* colorectal adenocarcinoma metastatic to
the liver

- Solitary or multiple metastatic tumors in the liver

- Metastatic involvement of the liver no greater than 40% of estimated liver
volume NOTE: *Must be from the hepatic tumor designated for study injection

- Metastatic liver tumors must be bidimensionally measurable by CT scan or MRI

- At least 1 metastatic liver tumor measuring at least 2.0 cm must be visualized by
ultrasound (US) and accessible for US-guided percutaneous injection

- Extrahepatic metastases allowed

- No prior or current ascites

- Ineligible for hepatic resection

PATIENT CHARACTERISTICS:

Age

- Adult

Performance status

- Karnofsky 70-100%

Life expectancy

- At least 16 weeks

Hematopoietic

- Granulocyte count at least 1,500/mm^3

- Hemoglobin at least 9.0 g/dL

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

Hepatic

- No clinical evidence of other severe liver disease (e.g., portosystemic
encephalopathy)

- PT no greater than 14 seconds

- Bilirubin no greater than 2.0 times upper limit of normal (ULN)

- Transaminases no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 45 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

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

- HIV negative

- No active infection

- No other concurrent serious medical illness

- No other malignancy within the past 5 years except inactive nonmelanoma skin cancer,
carcinoma in situ of the cervix, or grade 1 papillary bladder cancer

- Oriented and rational

- Weight at least 30 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

- At least 2 months since prior corticosteroids

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- At least 2 months since prior systemic immunosupppressive drugs

- No concurrent immunosuppressive drugs

- No concurrent anticoagulant therapy with heparin or warfarin

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Max W. Sung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

Unspecified

Study ID:

CDR0000335463

NCT ID:

NCT00072098

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • liver metastases
  • recurrent rectal cancer
  • recurrent colon cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Mount Sinai Medical CenterNew York, New York  10029