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Phase I Clinical Trial of Recombinant Viscumin (rViscumin, rMistletoe Lectin, rML) Administered Twice Weekly By The Intravenous Route In Patients With Solid Tumors After Failure of Standard Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Clinical Trial of Recombinant Viscumin (rViscumin, rMistletoe Lectin, rML) Administered Twice Weekly By The Intravenous Route In Patients With Solid Tumors After Failure of Standard Therapy


OBJECTIVES:

- Determine the maximum tolerated dose and dose-limiting toxicity of mistletoe lectin
(recombinant viscumin) in patients with advanced solid tumors who have failed standard
therapy.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine whether induction of antibodies against recombinant viscumin occurs in these
patients.

- Determine whether immunological stimulation at the RNA level of immune cells occurs in
patients treated with this regimen.

- Determine whether modification of endothelial parameters occurs in patients treated
with this regimen.

- Determine the objective response rates in patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Patients receive mistletoe lectin (recombinant viscumin) IV over 1 hour twice weekly.
Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-3 patients receive escalating doses of recombinant viscumin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients
experience dose-limiting toxicity during the first course. Additional patients are treated
at the MTD.

Patients are followed every 3 months until disease progression or initiation of another
therapy.

PROJECTED ACCRUAL: A minimum of 37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically proven progressive advanced solid tumor that is not
amenable to standard therapy (i.e., resistant to standard therapy or for which no
standard therapy exists)

- No clinically symptomatic CNS involvement

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

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

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

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)

- Alkaline phosphatase less than 2.5 times ULN (5 times ULN if liver metastases
present)

Renal:

- Creatinine less than 1.4 mg/dL

Cardiovascular:

- No ECG abnormalities of clinical relevance

Other:

- No severe or unstable systemic disease or infection

- No circumstances (e.g., alcoholism or substance abuse) that would preclude study
participation

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunostimulating substances, biologic response
modifiers, or colony-stimulating factors

- No concurrent immunostimulating substances, colony-stimulating factors (except in
life-threatening situations), biologic response modifiers, or monoclonal antibodies

Chemotherapy:

- At least 4 weeks since prior chemotherapy

Endocrine therapy:

- At least 4 weeks since prior hormonal therapy

- At least 4 weeks since prior systemic steroids

- No concurrent systemic steroids

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- No prior mistletoe preparations

- At least 4 weeks since prior investigational treatment

- No other concurrent anticancer agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick Schoffski, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Hannover Medical School

Authority:

United States: Federal Government

Study ID:

EORTC-16002

NCT ID:

NCT00006354

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

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