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Phase I Trial of Intravenous Recombinant Human TNF-α and Liposomal Doxorubicin in Patients With Advanced Solid Tumors or Lymphomas

Phase 1
18 Years
Not Enrolling
Solid Tumors, Lymphomas

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Trial Information

Phase I Trial of Intravenous Recombinant Human TNF-α and Liposomal Doxorubicin in Patients With Advanced Solid Tumors or Lymphomas

Inclusion Criteria:

- Patient must have a diagnosed solid tumor malignancy or lymphoma indicated for Caelyx

- Patient is refractory to all lines of standard therapy including biologics, chemo or
other therapies, or at least one line of therapy in those patients for whom no
standard treatment exists.

- Patient has measurable disease (defined as at least one lesion whose longest diameter
can be accurately measured as >1 cm).

- At least 2 weeks has elapsed since the completion of the last cycle of chemotherapy
and/or major surgery and the patient is fully recovered from this previous therapy or
surgery and any post-surgical complications.

- The patient has a normal cardiac ejection fraction on MUGA or Echocardiogram.

- ECOG performance status of 2 or less.

- Patient is at least 18 years of age.

- Patient is capable of giving informed consent.

- Patient of childbearing potential is using adequate birth control measures (e.g.,
abstinence, barrier method with spermicide; intrauterine device, implantable or
injectable contraceptives or surgical sterilization) for the duration of the study
and will continue to use such precautions for 12 months after receiving treatment.

Exclusion Criteria:

- Positive pregnancy test or known pregnancy.

- Participation in any other clinical trial

- Known hypersensitivity to the active substance or to any of the excipients (Albumin).

- Patients exposed to greater than 450 mg/m2 of doxorubicin or Caelyx.

- Patient has a creatinine > 1.5 x the upper limit of normal, chronic renal failure
requiring hemodialysis or peritoneal dialysis.

- Platelet count equal to or less than 50,000/mm3, Hemoglobin less than 9.0 g/dL, or an
ANC less than 1,000 /mm3.

- Patient has a Sa02 of less than 93% on room air.

- Patient with detectable ascites or portosystemic hypertension or cirrhosis.

- Patient with bilirubin > 2.0, AST or ALT above 2.5X the upper limit of normal, an
alkaline phosphatase above 2.5X the upper limit of normal.

- Hypercalcaemia > 12 mg/dl (2.99 mmol/l).

- Patients with contraindications to the use of vasopressor substances.

- Patient has presence of a transplanted solid organ (with the exception of a corneal
transplant > 3 months prior to screening) or bone marrow transplant.

- Patient has a history of a significant medical illness deemed by the principal
investigator or sub-investigators as unsuitable for the trial, for example:
Significant cardiovascular disease, e.g. congestive heart failure (New York Heart
Association Class II, III or IV), severe angina pectoris, cardiac arrhythmias,
myocardial infarction within a 3 month period prior to treatment, venous thrombosis,
occlusive peripheral arterial disease, recent pulmonary embolism. Severe pulmonary
dysfunction. A recent history of, or active peptic ulcer. Severe ascites. Known

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of a single dose of intravenous recombinant human tumor necrosis factor-α plus liposomal doxorubicin

Outcome Description:

MTD is the dose level below the one that produces 2 or more Dose-Limiting Toxicities

Outcome Time Frame:

Up to 22 days

Safety Issue:


Principal Investigator

Elke Jäger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Krankenhaus Nordwest, Frankfurt, Germany


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2013

Completion Date:

February 2015

Related Keywords:

  • Solid Tumors
  • Lymphomas
  • Lymphoma
  • Neoplasms