Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of recombinant human tumor necrosis factor-α (rhTNF-α) when given as a single dose intravenously and in combination with liposomal doxorubicin in human subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhTNF-α 25 µg/m² + Caelyx 40 mg/m² | Experimental | Cohort 2: rhTNF-α 25 µg/m² + Caelyx 40 mg/m² |
|
| rhTNF-α 50 µg/m² + Caelyx 40 mg/m² | Experimental | Cohort 3: rhTNF-α 50 µg/m² + Caelyx 40 mg/m² |
|
| rhTNF-α 100 µg/m² + Caelyx 40 mg/m² | Experimental | Cohort 4: rhTNF-α 100 µg/m² + Caelyx 40 mg/m² |
|
| rhTNF-α 150 µg/m² + Caelyx 40 mg/m² | Experimental | Cohort 5: rhTNF-α 150 µg/m² + Caelyx 40 mg/m² |
|
| rhTNF-α 200 µg/m² + Caelyx 40 mg/m² | Experimental | Cohort 6: rhTNF-α 200 µg/m² + Caelyx 40 mg/m² |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human TNF-α | Drug | Infusion will be done over 60 minutes, preferably via central venous catheter. Will immediately follow the infusion of Liposomal doxorubicin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of a single dose of intravenous recombinant human tumor necrosis factor-α plus liposomal doxorubicin | MTD is the dose level below the one that produces 2 or more Dose-Limiting Toxicities | Up to 22 days |
| Dose Limiting Toxicity (DLT) of a single dose of intravenous recombinant human tumor necrosis factor-α plus liposomal doxorubicin | Toxicity Criteria will be those listed in NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Any grade 3 cytokine release syndrome/acute infusion reaction or allergic and toxicity Grade 3 and above will be considered a DLT except:
| up to 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall tumor response using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | 4 weeks | |
| Caelyx/doxorubicin plasma levels | Caelyx/doxorubicin plasma levels will be measured at 0, 24, 48 and 192 hours post-dose by fluorimetry (excitation at 470nm, emission 590 nm) after liposomes have been disrupted in 70% ethanol, 0.3 N HCl |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elke Jäger, MD | Krankenhaus Nordwest, Frankfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Nordwest | Frankfurt | D-60488 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| rhTNF-α 250 µg/m² + Caelyx 40 mg/m² | Experimental | Cohort 7: rhTNF-α 250 µg/m² + Caelyx 40 mg/m² |
|
| rhTNF-α 25 µg/m² + Caelyx 30 mg/m² | Experimental | Cohort 1 rhTNF-α 25 µg/m² + Caelyx 30 mg/m² |
|
|
| Liposomal doxorubicin | Drug | Infusion over 60 minutes |
|
|
| Caelyx | Drug | Administration of Caelyx® will be done first, as infusion in 250 ml D5W, followed immediately by infusion of rhTNF-α. |
|
|
| Recombinant human TNF-α | Drug | Recombinant human TNF-α (Beromun) will be diluted in 250 mL of normal saline with albumin (2 mg/mL) to prevent adherence of the protein to the delivery apparatus. Infusion will be done over 60 minutes, preferably via central venous catheter, including PICC lines. |
|
|
| 0, 24, 48 and 192 hours post-dose |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
Not provided
Not provided
Not provided