Clinical Trial: Study of APN201 (Liposomal Recombinant Human Cu/Zn-Superoxide Dismutase) for the Prevention of Radiation-induced Dermatitis in Women With Breast Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-blind, Split-body, Placebo-controlled Phase Ib Study of APN201 (Liposomal Recombinant Human Cu/Zn-superoxide Dismutase) for the Prevention of Radiation-induced

Brief Summary:

The standard treatment for early-stage breast cancer is breast-conserving surgery followed by adjuvant radiation therapy to the whole breast. This approach leads to low recurrence rates with a good cosmesis and provides an effective alternative to mastectomy. However, in most women receiving radiotherapy radiation dermatitis occur to some degree.

Radiation dermatitis generally manifests within a few weeks after the start of radiation therapy. Its onset varies depending on the radiation dose intensity and the normal tissue sensitivity of individuals. As the cumulative dose of radiation increases the transient erythema occurring during the first weeks of radiotherapy may evolve into the more persistent erythema and to dry or even moist desquamation that reflects the damage to the basal cell layer and the sweat and sebaceous glands.

There is currently no evidence that prophylactic treatments, beyond keeping the irradiated area clean and dry, are effective in reducing the incidence or severity of radiation dermatitis (Bolderston et al. 2006).

However, together with other enzymes of the peroxidase pathway, SOD scavenges the superoxide, hydroxyl, and other oxygenated free radicals (Klug et al. 1972; Tainer at al. 1983). In physiological conditions, the production of free radicals (Monte & Sacerdote 1994) and the action of antiradicals' enzymes is balanced. Following tissue injuries, either pathological or caused by agents such as radiation therapy, an excess production of free radicals is observed (Petkau 1986; Lorette & Machet 2001). Furthermore, basal SOD is increased in breast cancer patients before radiation therapy as compared to controls (Seth et al. 2003), and decreases after radiotherapy (Ray at al. 2000). Hence, liposomal rhSOD applied during radiotherapy could b

Detailed Summary:
Sponsor: Apeiron Biologics

Current Primary Outcome: To evaluate safety and tolerability of APN201 [ Time Frame: From baseline until 1 day following the final radiotherapy fraction, assessed for a maximum of 28 radiotherapy fractions. ]

Adverse events, vital signs and laboratory assessments (hematology, serum chemistry) are used for safety evaluations.


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the efficacy of APN201 in the prevention of radiation-induced dermatitis [ Time Frame: From baseline until 1 day after the final radiotherapy fraction, assessed for a maximum of 28 radiotherapy fractions. ]

The following parameters are used for efficacy evaluations:

  • Time to ≥ grade 2 radiation dermatitis
  • Incidence of ≥ grade 2 radiation dermatitis
  • Severity of radiation dermatitis
  • Pain intensity (pain on touching the skin) due to radiation therapy
  • Irradiated skin evaluations using the digital wound documentation system W.H.A.T. (wound healing analysing tool) and a spectrophotometer


Original Secondary Outcome: Same as current

Information By: Apeiron Biologics

Dates:
Date Received: December 14, 2011
Date Started: January 2012
Date Completion:
Last Updated: July 12, 2013
Last Verified: July 2013