Neoplasms Clinical Trial
Although Neopharm has terminated its sponsorship of this study, it is continuing under the
sponsorship of the NCI. Please contact Raffit Hassan, MD at 301-451-8742 for more
information. Also see the related NCI study "Experimental Drug SS1(dsFv)-PE38 to Treat
Cancer" (Study ID number 010011).
SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high
affinity, disulfide stabilized antibody. The fused protein retains cell killing activity,
but binds only to cells expressing mesothelin. Tumors characterized by very high surface
mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum;
and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and
neck cancers.
This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous
SS1(dsFv)-PE38 administered once every other day for six doses. Dose escalation will proceed
in cohorts of 3 until dose-limiting toxicity (DLT) is observed.
OBJECTIVES: I. Determine the toxicities and maximum tolerated dose (MTD) of six doses of
SS1(dsFv)-PE38 QOD administered by intravenous infusion to patients with advanced
malignancies.
II. Characterize the plasma pharmacokinetics of SS1(dsFv)-PE38 after intravenous infusion.
III. Determine toxicities attributable to subsequent courses of SS1(dsFv)-PE38.
IV. Evaluate the response of selected advanced malignancies to intravenous infusion of six
doses of SS1(dsFv)-PE38 QOD administered at the MTD.
V. Determine the induction of antibody against SS1(dsFv)-PE38 and its relationship to
pharmacokinetics.
PROTOCOL OUTLINE: To exclude immediate allergic hypersensitivity reaction, each patient will
receive a test dose of SS1(dsFv)-PE38, and be observed for 30 minutes prior to receiving
study dosing. Each treatment will be given by intravenous infusion over 30 minutes every
other day. Hydration will be maintained. (Oral hydration may be adequate, but intravenous
hydration may be used at the Investigator?s discretion.) Patients will be observed for at
least 4 hours after infusion on Day 1 of each treatment course to exclude immediate allergic
reaction. Treatment may be repeated for a maximum of two additional courses after 4 weeks if
re-treatment criteria are met. At least three patients will be accrued at each dose level.
Dose escalation within a patient will not be allowed.
PROJECTED ACCRUAL: Up to 30 patients
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
| Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
| Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
| Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
| Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
| Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
| Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
| Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
| Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
| Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
| Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
| Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
| Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
| Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
| Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
| Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
| Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
| Completed |
NCT03190811 -
Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors
|
Phase 1/Phase 2 |